Apparatus, process and system for monitoring a plurality of patients affected by kidney failure

ABSTRACT

An apparatus, a process and a system for monitoring a plurality of patients (P) affected by kidney failure over a time frame (T) are disclosed. The system includes blood treatment units, laboratory storage units, at least one hub module, and client units. The system collects values (VM) of a plurality of session parameters, set values (VS) of a plurality of prescription parameters, values (VL) of a plurality of laboratory parameters and the hub module stores values (KPVi) of selected parameters (KPi) which are a subclass of the collected values (VM, VS, VL) and which are transferred to the client units. Each client unit may define, for each of said patients, a number of indicators (IDk) based on the values (KPVi,k) taken by a respective subclass (KPi,k) of said selected parameters (KPi) and to operate the respective display according to various display modes.

RELATED APPLICATIONS

This application claims the benefit under 35 U.S.C. § 119(e) of U.S.Provisional Application No. 61/562,909, filed 22 Nov. 2011 and alsoclaims priority to Italian Application No. M12012A000100, filed 27 Jan.2012.

An apparatus, process and system for monitoring a plurality of patientsaffected by kidney failure are described herein. In one or moreembodiments, the apparatus, process and system are configured to monitora plurality of patients over a time frame such that an operator, e.g. amedical doctor, may be able to more easily survey his patients. In oneor more embodiments, the apparatus, process and system may serve, forexample, to timely identify those patients who would need a treatmentprescription modification, or those patients who would deserve moredetailed exams to confirm a potential risk of developing a pathology,etc.

BACKGROUND

It is known that patients affected by kidney failure need to beperiodically treated in order to eliminate excess of water and in orderto reinstate the proper acid-base and electrolyte equilibrium in blood.These patients may be treated using extracorporeal blood treatmentmachines which are designed to withdraw blood from a patient, treat theblood and then return the treated blood to the patient.

On occasion of each treatment, a blood treatment machine is properlyconfigured with the disposable components (such as the tubing lines, thehemofilter or dialyzer, the concentrates); then, after few start-upphases, normally including priming of the extracorporeal circuit, apatient's cardiovascular system is connected with the extracorporealcircuit of the blood treatment machine and a number of parametersrelating to operation of the machine or to the treatment to be deliveredto the patient are set, typically before starting the treatment.Furthermore, in the course of the treatment, a multiplicity of sensorscaptures the values of a number of sensed parameters which are keptunder surveillance. In conclusion, considering that each patientreceives 3 or 4 dialysis sessions per week, a relevant number ofinformation is captured and stored on a weekly basis. It should also benoted that patients are often submitted to blood sampling and testing atlaboratory units in order to measure concentration of certain substancesin blood, which may serve to understand the health status of thepatient. In this situation, a huge amount of data is continuouslycollected for each patient.

It is known to centralize and to make available in specialized clinicalinformation systems the medical status and the dialysis prescription ofthe patients. In other words, all collected information is kept indatabases and a medical doctor willing to have the full picture of apatient may need to consult a huge number of parameter values coming atdifferent moments and from different sources with no possibility tocorrelate the various parameters to a meaningful clinical picture. Thislarge amount of information may render basically impossible to a medicaldoctor efficiently identifying relevant information and to correlatecertain information with risks to have or contract certain pathologies.Even more difficult is correlating relevant data of one patient withthose of other patients: the status of a patient population of adialysis center is not made available to the medical doctor in a fastand consistent way. To the contrary, data which may refer to a sameaspect of the dialysis treatment or of the patient are often scatteredin several files, papers and databases. Thus the medical doctor cannothave an overview of the quality of care delivered to his patients andcannot take prompt action at an early stage.

SUMMARY

In one or more embodiments, the apparatus, process and system describedherein may offer a technical solution adapted to more easily gather andcorrelate a variety of information relating to a patient population.

In one or more embodiments, the apparatus, process and system describedherein may provide a solution allowing the user to have an efficienttool to visualize a plurality of key aspects related to the status of arelevant number of patients.

In one or more embodiments, the apparatus, process and system describedherein may offer a technical solution capable of consolidating in fewindicators the overall analysis of patient status thus efficientlystoring and/or transferring key information without requiringcollection/transmission of huge amount of data.

Furthermore, in one or more embodiments, the apparatus, process andsystem described herein may render available a technical solution whichallows to visualize a number of information with different types ofconsolidation criteria and which allows easy and intuitive navigationthrough the various modes of visualization.

Moreover, in one or more embodiments, the apparatus, process and systemdescribed herein may be provide a solution adapted to permit reviewing alarge population of dialysis patients, orienting the doctors to thepatients with the biggest drifts from normality.

In one or more embodiments, the apparatus, process and system describedherein may allow an in depth analysis of an impaired quality indicatorto provide real time evaluation of the quality of the treatmentdelivered to the patients.

In one or more embodiments, the apparatus, process and system describedherein may provide at least one of the above solutions.

Aspects of one or more embodiments of the apparatus, process and systemdescribed herein may are described below.

A 1st aspect concerns, in one or more embodiments, an apparatus ofmonitoring a plurality of patients (P) affected by kidney failure over atime frame (T), the apparatus comprising a memory (101), a graphic userinterface (102), and a control unit (103) connected to the memory and tothe graphic user interface, the apparatus being configured for beinginserted in a system configured for:

-   -   collecting one or more of:        -   values (V_(M)) of a plurality of session parameters measured            by sensors of blood treatment machines (300) in the system            during respective blood treatment sessions of each patient            over said time frame,        -   set values (V_(S)) of a plurality of prescription            parameters,        -   values (V_(L)) of a plurality of laboratory parameters            comprising values relating to biological fluid properties            obtained from tests conducted on fluid samples taken from            each patient over said time frame,    -   storing, in a memory (201) of a hub module (200) part of the        system, values (KPV_(i)) of selected parameters (KP_(i))        comprising:        -   values of a first subgroup of said plurality of session            parameters (V_(M)),        -   set values of a second subgroup of said plurality of            prescription parameters (V_(S)), and        -   values of a third subgroup of said plurality of laboratory            parameters (V_(L)),

wherein the apparatus control unit (103) is configured to:

-   -   receive and store in the apparatus memory (101), for each        patient (P), a prescribed number of the values (KPV_(i))        contained in the hub module memory (201),    -   define, for each of said patients, a number of indicators        (ID_(k)) wherein each of said indicator is distinct from the        other and is defined based on the values (KPV_(i,k)) taken by a        respective subclass (KP_(i,k)) of said selected parameters        (KP_(i));    -   operate in a first display mode comprising generating on said        graphic user interface (102) a first display (110) having a        first selection tool (111) for choosing one among said selected        parameters (KP_(i)) and a first display field (112) showing, for        each of a plurality of patients, a respective graphic        representation (113) of one or more significant values taken by        the chosen parameter across said time frame (T);    -   operate in a second display mode comprising generating on said        graphic user interface (102) a second display (120) having a        second selection tool (121) for choosing one among said        indicators (ID_(k)) and a second display field (122) showing,        for one patient, a graphic representation (123) of the values        (KPV_(i,k)) taken, over the time frame (T), by the subclass of        said selected parameters (KP_(i,k)) affecting the selected        indicator (ID_(k));    -   allow, when in said first display mode, choosing one patient and        detecting selection of said one patient; and subsequently    -   activate said second display mode and display said second        display (120) on the graphic user interface (102) wherein, in        the second display mode, graphic representations (123) are        displayed of the values (KPV_(i,k)) taken, over the time frame        (T), by the subclass of said selected parameters (KP_(i,k))        affecting the selected indicator (ID_(k)) and relating to the        chosen patient.

In a 2nd aspect, according to the 1st aspect, the control unit (103) is,in one or more embodiments, configured to remotely connect with the hubmodule (200) and receive, at time intervals, the values (KPV_(i)) ofselected parameters (KP_(i)) contained in the hub module memory (201).

In a 3rd aspect, according to the 2nd aspect, the control unit (103) is,in one or more embodiments, configured to interrogate the hub module(200) at a plurality of regular time intervals during said time frame(T) in order to collect a plurality of sets of values (KPV_(i)) ofselected parameters (KP_(i)), each set referring to a respective timeinterval.

In a 4th aspect according to any one of the preceding aspects, thecontrol unit (103) is, in one or more embodiments, configured to hidesaid first display (110) when said second display mode is activated.

In a 5th aspect according to any one of the preceding aspects, thecontrol unit (103) is, in one or more embodiments, configured to displaysaid the representations (113) in side by side relation in said firstdisplay field (112).

In a 6th aspect according to any one of the preceding aspects, thecontrol unit (103), in said first display mode, is, in one or moreembodiments, configured to detect the patient chosen by detectingselection of one of said first graphic representations (113).

In a 7th aspect according to any one of the preceding aspects, thecontrol unit (103), in said first display mode, is, in one or moreembodiments, configured to detect the patient chosen by detectingselection of one of said first graphic representations (113); anddetecting selection of one of said graphic representations (113)comprises detecting overlapping of a graphic selector (114) with thechosen one among said first graphic representations, the graphicselector (114) optionally graphically differentiating the chosen firstgraphic representation from the other first graphic representationsdisplayed on the first display.

In an 8th aspect according to any one of the preceding two aspects, thegraphic user interface (102), in one or more embodiments, comprises atouch screen and wherein detecting selection of one of said graphicrepresentations (113) comprises detecting touching of a touch screenarea where the graphic representation (113) is displayed.

In a 9th aspect according to any one of the preceding three aspects,detecting selection of one of said graphic representations (113)comprises, in one or more embodiments, detecting entry of a confirmationindicative that the user intends to switch to the second display mode.

In a 10th aspect according to any one of the preceding aspects, thecontrol unit (103) is, in one or more embodiments, configured to displaya menu area (130), optionally in the form of a menu bar, comprising aplurality of selectable areas (131, 132, 133), the plurality ofselectable areas comprising at least a first selectable area (131) and asecond selectable area (132), wherein the control unit is furtherconfigured to detect selection of the first selectable area and toactivate the first display mode when the first selectable area isselected.

In an 11th aspect according to the preceding aspect, the control unitis, in one or more embodiments, further configured to detect selectionof the second selectable area (132) and to activate the second displaymode when the second selectable area is selected.

In a 12th aspect according to any one of the preceding two aspects, thecontrol unit (103) is, in one or more embodiments, configured to displaythe menu area (130) both in said first and in said second display modes.

In a 13th aspect according to the preceding aspect, the control unit(103) is, in one or more embodiments, configured to graphicallydifferentiate the first and second selectable areas respectively whenthe first or the second display mode is activated to provide a user of agraphic indication of which mode is active.

In a 14th aspect according to any one of the preceding aspects, thefirst display field (112), in one or more embodiments, comprises aCartesian representation where one axis (115) represents the patientsand one other axis (116) represents the measure of the values taken bythe selected parameters (KP_(i)), and wherein each of said first graphicrepresentations (113) comprises a representation of the mean value takenby the selected parameter across said time frame (T) and a graphicrepresentation of a distribution of values taken by the selectedparameter around said mean value.

In a 15th aspect according to any one of the preceding aspects, thecontrol unit (103), in said first display mode, is, in one or moreembodiments, configured to display on said graphic user interface anauxiliary display (150) comprising a table displaying a list of themonitored patients, the control unit being also configured to associatean identification code to each patient and to detect the patient chosenby detecting selection of the respective identification code.

In a 16th aspect according to any one of the preceding aspects, thecontrol unit (103), in said first display mode, is, in one or moreembodiments, configured to display on said graphic user interface arecap display (160) comprising a table (161) displaying a list (162) ofmonitored patients, a list (163) of said indicators (ID_(k)), and ascore (164) associated to a number of indicators and patients, whereineach of the displayed scores is univocally associated to a respectivepatient and to a respective indicator (ID_(K)), the control unit beingconfigured to calculate each one of said scores (164) based on acomparison of each of the values (KPV_(i,k)) taken, for the respectivepatient, by the subclass of said selected parameters (KP_(i,k))affecting the indicator (ID_(k)), with a respective reference criterion.

In a 17th aspect according to any one of the preceding two aspects, thecontrol unit (103) is, in one or more embodiments, configured todisplay, when in said first display mode, a switching tool (170) foralternatively displaying one of the first display, the auxiliary displayand the recap display.

In a 18th aspect according to the preceding aspect, the control unit(103) is, in one or more embodiments, further configured for associatingto each of said scores a different graphic representation, optionally adifferent background texture, color or a different size, depending uponthe score value.

In a 19th aspect according to any one of the preceding aspects, thesecond selection tool (121) comprises, in one or more embodiments, aplurality of selectable zones (128), each of said selectable zonescorresponding to a respective one of said indicators (ID_(k)), whereinthe control unit (103) is further configured to:

-   -   detect selection of one indicator by detecting selection of the        corresponding selectable zone (128), and    -   display on said second display (120) the graphic representations        (123) of the values (KPV_(i,k)) taken, over the time frame (T),        by the subclass of said selected parameters (KP_(i,k)) affecting        the selected indicator (ID_(k)) and relating to the chosen        patient.

In a 20th aspect according to any one of the preceding aspects, theselectable zones (128), in one or more embodiments, are displayed inside by side relation and define at least one navigation bar.

In a 21st aspect according to any one of the preceding aspects, thecontrol unit (103) is, in one or more embodiments, configured to allowsetting of said time frame (T), optionally wherein the control unit isconfigured to display in said first display mode a time frame selectiontool (170) allowing to set at least one of:

-   -   a start of said time frame (T),    -   an end of said time frame (T),    -   a start and an end of said time frame (T).

In a 22nd aspect according to any one of the preceding aspects, thecontrol unit (103), in one or more embodiments, is configured to allowsetting of a population filtration criterion.

In a 23rd aspect according to any one of the preceding aspects, thecontrol unit (103), in one or more embodiments, is configured to:

-   -   store in said memory a plurality of population filtration        criteria,    -   display in said first display mode a population filtration tool        (180) for the selection of one population filtration criterion;    -   detect the setting of a population filtration criterion.

In a 24th aspect according to any one of the preceding two aspects, thecontrol unit, when in said first display mode, is configured, in one ormore embodiments, to display the respective graphic representation (113)of said one or more significant values, only for those patientssatisfying the set population filtration criterion.

In a 25th aspect according to any one of the preceding three aspects,the control unit, when in said first display mode, is, in one or moreembodiments, configured to allow choosing one patient only among thosesatisfying the set population filtration criterion.

In a 26th aspect according to any one of the preceding aspects from 22to 25 said population filtration criteria, in one or more embodiments,comprises a condition concerning one or more of the values (KPV_(i)) ofselected the parameters (KP_(i)).

In a 27th aspect according to any one of the preceding aspects from 22to 26 said population filtration criteria, in one or more embodiments,comprises conditions concerning one or more of said indicators (ID_(k)).

In a 28th aspect according to any one of the preceding aspects thecontrol unit (103), in one or more embodiments, is configured to:

-   -   allow an operator to choose one or more indicators (ID_(k)) of        interest,    -   receive and store in the apparatus memory (101), for each        patient (P), only the values (KPV_(i)) contained in the hub        module memory (201) taken, over the time frame (T), by the        subclass of said selected parameters (KP_(i,k)) affecting the        chosen indicators (ID_(k)).

In a 29th aspect according to any one of the preceding aspects from 22to 28,the control unit (103), in one or more embodiments, is configuredto request a scan of the hub module memory (201), and receive and storein the apparatus memory exclusively the values (KPV_(i)) of selectedparameters (KP_(i)) relating to patients satisfying the populationfiltration criterion.

In a 30th aspect according to any one of the preceding aspects thecontrol unit, in one or more embodiments, is configured to:

-   -   allow, when in said second display mode, a choice of one among        the values taken by the parameters of said subclass of selected        parameters (KP_(i,k)) affecting the selected indicator (ID_(k));    -   establish the treatment session corresponding to the chosen        value;    -   operate in a third display mode, comprising generating a third        display (140) on said graphic user interface (102) having a        third display field (142) showing, for the chosen patient and        for the treatment session corresponding to the chosen value, a        respective graphic representation (143) of plurality of values        taken at different instants over session treatment time by said        a plurality parameters.

In a 31st aspect according to any one of the preceding aspects from 16to 30, the control unit, in one or more embodiments, is configured tocalculate a sum and/or a mean value of said scores (164) referring to asame patient.

In a 32nd aspect according to the preceding aspect the control unit, inone or more embodiments, is configured to rank patients from the onehaving highest score to the one having lowest score.

A 33rd aspect concerns, in one or more embodiments, a process ofmonitoring a plurality of patients affected by kidney failure over atime frame covering a plurality of blood treatment sessions, the processcomprising:

at a hub module (200), receiving for each one of the plurality ofpatients, values (V) taken by a plurality of patient parameters atdifferent time instants during the time frame (T), said values of theplurality of patient parameters including, for each patient one or moreof:

-   -   values (V_(M)) of a plurality of session parameters measured by        sensors of a blood treatment machine (300) during each blood        treatment session of each patient over said time frame,    -   values (V_(L)) of a plurality of laboratory parameters obtained        from tests conducted on fluid samples taken from each patient        over said time frame (T) and stored in one or more laboratory        storage units (400),    -   set values (V_(S)) of a plurality of prescription parameters set        for each blood treatment session and each patient on each of        said blood treatment machines (300) over said time frame,

the hub module (200) being remotely connected to the blood treatmentmachines (300) and to laboratory storage units (400),

the process further comprising:

-   -   creating, at hub module, a key parameter log (202) storing the        values (KPV_(i)) of selected parameters (KP_(i)) including:        -   a first subgroup comprising, for each monitored patient,            values of a selection of the plurality of session parameters            (V_(M)),        -   a second subgroup comprising, for each monitored patient,            set values of a selection of the plurality of prescription            parameters (V_(S)), and        -   a third subgroup comprising, for each monitored patient,            values of a selection the plurality of laboratory parameters            (V_(L)),    -   defining, either at the hub module or at client units (100)        remotely located from the hub module (200), a number of        indicators (ID_(k)) for each of said patients, wherein each of        said indicators is distinct from the other and is defined based        on the values (KPV_(i,k)) taken by a respective sub-group        (KP_(i,k)) of said plurality of patient parameters (KP_(i));    -   at client units (100) comparing all or some of the values        (KPV_(i,k)) taken, over the time frame (T), by the subclasses of        selected parameters (KP_(i,k)) affecting a same indicator        (ID_(k)) with respective reference criteria and signaling        whether or not one or more of said criteria are not met.

A 34th aspect concerns, in one or more embodiments, a process ofmonitoring a plurality of patients affected by kidney failure over atime frame covering a plurality of blood treatment sessions, the processusing a hub module (200) remotely connected to the blood treatmentmachines (300) and to laboratory storage units (400), the hub modulecomprising a respective control unit (203) and a respective memory, theprocess comprising:

collecting, for each one of the plurality of patients, values (V) takenby a plurality of patient parameters at different time instants duringthe time frame (T), said values of the plurality of patient parametersincluding, for each patient:

-   -   values (V_(M)) of a plurality of session parameters measured by        sensors of a blood treatment machine (300) during each blood        treatment session of each patient over said time frame,    -   values (V_(L)) of a plurality of laboratory parameters obtained        from tests conducted on fluid samples taken from each patient        over said time frame (T) and stored in one or more laboratory        storage units (400),    -   set values (V_(S)) of a plurality of prescription parameters set        for each blood treatment session and each patient on each of        said blood treatment machines (300) over said time frame,

scanning the collected values (V) and selecting values (KPV_(i)) ofselected parameters (KP_(i)) comprising:

-   -   selecting a first subgroup comprising, for each monitored        patient, values of a selection of the plurality of session        parameters (V_(M)),    -   selecting a second subgroup comprising, for each monitored        patient, set values of a selection of the plurality of        prescription parameters (V_(S)), and    -   selecting a third subgroup comprising, for each monitored        patient, values of a selection the plurality of laboratory        parameters (V_(L)), storing in the hub module memory (201)        exclusively the selected values (KPV_(i)) of the selected        parameters (KP_(i));

defining, for each of said patients, a number of indicators (ID_(k))wherein each of said indicator is distinct from the other and is definedbased on the values (KPV_(i,k)) taken by a respective sub-group(KP_(i,k)) of said plurality of patient parameters (KP_(i));

at client units (100) remotely located from the hub module (200),receiving the selected values (KPV_(i)) of the selected parameters(KP_(i)) and comparing all or some of the values (KPV_(i,k)) taken, overthe time frame (T), by the subclasses of selected parameters (KP_(i,k))affecting a same indicator (ID_(k)) with respective reference criteriaand signaling whether one or more of said criteria are not met.

A 35th aspect concerns, in one or more embodiments, a system formonitoring a plurality of patients affected by kidney failure over atime frame covering a plurality of blood treatment sessions, the systemcomprising:

-   -   a plurality of blood treatment machines (300) for the treatment        of the monitored patients, each blood treatment machine (300)        including at least one respective control unit (301) and sensors        (302) for measuring session parameters, the control unit of each        blood treatment machine being configured to:        -   receive from the sensors (302) signals corresponding to            values (V_(M)) of a plurality of session parameters measured            during each blood treatment session for each patient, and        -   receive set values (V_(S)) of a plurality of prescription            parameters, said set values of prescription parameters            comprising values of a plurality of session parameters which            are set on said blood treatment machines for the blood            treatment sessions of each patient over said time frame (T);    -   a number of laboratory storage units (400) configured to store        values (V_(L)) of laboratory parameters relating to patient        blood properties obtained from tests conducted on fluid samples        taken from each patient;    -   a hub module (200) communicatively connected to the blood        treatment machines (300) and to the laboratory storage units        (400), the module comprising a control unit (203) configured to:        -   receive from said blood treatment machines and for each            monitored patient, values (V_(M)) of the plurality of            session parameters measured by the sensors of each blood            treatment machine during each blood treatment session of            each patient over said time frame (T),        -   receive from said blood treatment machines and for each            monitored patient, set values of (V_(S)) of prescription            parameters set for each blood treatment session of each            patient over said time frame,        -   receive from the laboratory storage units values (V_(L)) of            laboratory parameters obtained from tests conducted on fluid            samples taken from each patient over said time frame, and        -   create a key parameter log (202) storing values (KPV_(i)) of            selected parameters (KP_(i)) comprising:            -   values of a first subgroup of said plurality of session                parameters (V_(M)),            -   set values of a second subgroup of the plurality of                prescription parameters (V_(S)),            -   values of a third subgroup of said plurality of                laboratory parameters (V_(L)); and    -   a plurality of client units (100) each configured for reading        the data coming from the key parameter log (202) and each        further configured to:        -   store, for each patient, the values (KPV_(i)) of the            selected parameters (KP_(i)) contained in the key parameter            log (202),        -   define, for each of said patients, a number of indicators            (ID_(k)) wherein each of said indicator is distinct from the            other and is defined based on the values (KPV_(i,k)) taken            by a respective subclass (KP_(i,k)) of said selected            parameters (KP_(i)),        -   compare the values (KPV_(i,k)) taken, over the time frame            (T), by the subclasses of selected parameters (KP_(i,k))            affecting a same indicator (ID_(k)) with respective            reference criteria;        -   signal whether one or more of said criteria are not met.

A 36th aspect concerns, in one or more embodiments, a system formonitoring a plurality of patients affected by kidney failure over atime frame covering a plurality of blood treatment sessions, the systemcomprising:

-   -   a plurality of blood treatment machines (300) for the treatment        of the monitored patients, each blood treatment machine (300)        including at least one respective control unit (301) and sensors        (302) for measuring session parameters, the control unit of each        blood treatment machine being configured to:        -   receive from the sensors (302) signals corresponding to            values (V_(M)) of a plurality of session parameters measured            during each blood treatment session for each patient, and        -   receive set values (V_(S)) of a plurality of prescription            parameters, said set values of prescription parameters            comprising values of a plurality of session parameters which            are set on said blood treatment machines for the blood            treatment sessions of each patient over said time frame (T);    -   a number of laboratory storage units (400) configured to store        values (V_(L)) of laboratory parameters relating to patient        blood properties obtained from tests conducted on fluid samples        taken from each patient;    -   a hub module (200) communicatively connected to the blood        treatment machines (300) and to the laboratory storage units        (400), the module comprising a control unit (203) configured to:        -   receive from said blood treatment machines and from the            laboratory storage units values (KPV_(i)) of selected            parameters (KP_(i)) comprising:            -   values of a first subgroup of said plurality of session                parameters (V_(M)),            -   set values of a second subgroup of the plurality of                prescription parameters (V_(S)),            -   values of a third subgroup of said plurality of                laboratory parameters (V_(L)); and        -   store said values (KPV_(i)) of the selected parameters            (KP_(i)) in a hub module memory (201);    -   a plurality of client units (100) each configured for receiving        values (KPV_(i)) of the selected parameters (KP_(i)) coming from        the hub module memory (201) and each further configured to:        -   store, for each patient, the values (KPV_(i)) of the            selected parameters (KP_(i)) received from the hub module            memory (201),        -   define, for each of said patients, a number of indicators            (ID_(k)) wherein each of said indicator is distinct from the            other and is defined based on the values (KPV_(i,k)) taken            by a respective subclass (KP_(i,k)) of said selected            parameters (KP_(i)),        -   compare the values (KPV_(i,k)) taken, over the time frame            (T), by the subclasses of selected parameters (KP_(i,k))            affecting a same indicator (ID_(k)) with respective            reference criteria;        -   signal whether one or more of said criteria are not met.

In a 37th aspect according to aspect 35 or 36, each client unit is, inone or more embodiments, further configured for interrogating at timeintervals (t) the hub module and receiving all or a prefixed number ofthe values (KPV_(i)) of the selected parameters (KP_(i)) contained inthe hub module memory.

In a 38th aspect according to aspect 35 or 36 or 37, the hub moduleprocessing unit is, in one or more embodiments, further configured totransmit all or a prefixed number of the values (KPV_(i)) of theselected parameters (KP_(i)) to each of said client units.

In a 39th aspect according to any one of aspects from 35 to 38, the hubmodule processing unit is, in one or more embodiments, configured toreceive from said blood treatment machines and for each monitoredpatient, set values of (V_(S)) of prescription parameters set for eachblood treatment session of each patient over said time frame, said setvalues of prescription parameters comprising one or more in the groupof:

-   -   values of a plurality of session parameters set for blood        treatment sessions of each patient over said time frame,    -   values representative of medicament prescriptions which have        been imparted to each patient over said time frame,    -   values representative of one or more disposable items used        during blood treatment sessions of each patient over said time        frame.

In a 40th aspect according to any one of aspects from 35 to 39, eachclient unit, in one or more embodiments, includes an apparatus accordingto any one of the preceding aspects from 1 to 32.

In a 41st aspect according to any one of aspects from 35 to 40, thesystem further comprises, in one or more embodiments, an intermediateelaborating unit, the intermediate unit being communicatively interposedbetween the hub module and the blood treatment machines, wherein thevalues coming from a number of blood treatment apparatus are collectedby the intermediate unit before being transmitted to the hub module, andwherein the intermediate unit is configured to transmit said collectedvalues either at time intervals or upon request to the hub module.

In a 42nd aspect according to any one of aspects from 35 to 41, thesystem further comprises, in one or more embodiments, a furtherintermediate elaborating unit, the further intermediate unit beingcommunicatively interposed between the hub module and the number oflaboratory storage units, wherein the values coming from a number oflaboratory storage units are collected by the further intermediate unitbefore being transmitted to the hub module, and wherein the furtherintermediate unit is configured to transmit said collected values eitherat time intervals or upon request to the hub module.

In a 43rd aspect according to any one of the preceding two aspects, thehub module is, in one or more embodiments, one of:

-   -   physically remote from the intermediate unit,    -   physically remote from both the intermediate unit and the        further intermediate unit,    -   physically part of the intermediate unit, this latter being        remotely connected to the plurality of blood treatment machines,    -   physically part of the further intermediate unit, this latter        being remotely connected to the plurality of laboratory storage        units.

In a 44th aspect according to aspect 33 or 34, the process, in one ormore embodiments, comprises, at each client unit, interrogating at timeintervals (t) the hub module and receiving all or a prefixed number ofthe values (KPV_(i)) of the selected parameters (KP_(i)) contained inthe hub module memory.

In a 45th aspect according to aspect 33 or 34 or 44, the hub module, inone or more embodiments, transmits all or a prefixed number of thevalues (KPV_(i)) of the selected parameters (KP_(i)) to each of saidclient units.

In a 46th aspect according to aspect 33 or 34 or 44 or 45, the hubmodule, in one or more embodiments, receives from said blood treatmentmachines and for each monitored patient, set values of (V_(S)) ofprescription parameters set for each blood treatment session of eachpatient over said time frame, said set values of prescription parameterscomprising one or more in the group of:

-   -   values of a plurality of session parameters set for blood        treatment sessions of each patient over said time frame,    -   values representative of medicament prescriptions which have        been imparted to each patient over said time frame,    -   values representative of one or more disposable items used        during blood treatment sessions of each patient over said time        frame.

In a 47th aspect according to aspect 33 or 34 or 44 or 45 or 46, eachclient unit, in one or more embodiments, includes an apparatus accordingto any one of the preceding claims 1-32.

In a 48th aspect according to aspect 33 or 34 or 44 or 45 or 46 or 47,an intermediate elaborating unit is, in one or more embodiments,communicatively interposed between the hub module and the bloodtreatment machines, wherein the values coming from a number of bloodtreatment apparatus are collected by the intermediate unit before beingtransmitted to the hub module, and wherein the intermediate unittransmits said collected values either at time intervals or upon requestby the hub module.

In a 49th aspect according to aspect 33 or 34 or 44 or 45 or 46 or 47 or48, a further intermediate elaborating unit is, in one or moreembodiments, communicatively interposed between the hub module and thelaboratory storage units, wherein the values coming from a number oflaboratory storage units are collected by the further intermediate unitbefore being transmitted to the hub module, and wherein the furtherintermediate unit transmits said collected values either at timeintervals or upon request to the hub module.

A 50th aspect concerns a system according to aspect 48 or 49, whereinthe hub module is, in one or more embodiments, one of:

-   -   physically remote from the intermediate unit,    -   physically remote from both the intermediate unit and the        further intermediate unit,    -   physically part of the intermediate unit, this latter being        remotely connected to the plurality of blood treatment machines,    -   physically part of the further intermediate unit, this latter        being remotely connected to the plurality of laboratory storage        units.

In a 51st aspect according to any one of the preceding aspects, thevalues, in one or more embodiments, of the first subgroup of saidplurality of session parameters (V_(M)) include measured values for oneor more of the following parameters:

-   -   blood flow rate,    -   clearance or dialysance values,    -   treated blood volume,    -   K*Tr and or K*Tr/V where K is measured dialysance, Tr is        treatment time and V a reference volume,    -   dialysate conductivity,    -   patient blood conductivity at the beginning and/or at the end of        the treatment session,    -   transferred ionic mass,    -   total weight loss,    -   real session duration,    -   measures of cardiac parameters: systolic and diastolic arterial        pressure (TA), cardiac rate,    -   arterial and/or venous pressure,    -   hemoglobin, e.g. obtained by calorimetric detection.

In a 52nd aspect according to any one of the preceding aspects, the setvalues, in one or more embodiments, of the second subgroup of saidplurality of prescription parameters (V_(S)) include, for each bloodtreatment session of each patient over said time frame T, the following:

-   -   duration of the blood treatment session,    -   blood conductivity,    -   blood flow rate,    -   patient's dry weight,    -   the calcium concentration for the dialysis liquid,    -   the potassium concentration for the dialysis liquid,    -   the blood flow rate in the extracorporeal circuit,    -   the weight loss rate,    -   the total weight loss to be achieved at the end of the        treatment,    -   the blood conductivity to be achieved at the end of the        treatment,    -   the dialysis dose.

In a 53rd aspect according to any one of the preceding aspects, theprescription parameters, in one or more embodiments, also include valuesindicative of the disposables used on each session, including valuesindicative of one or more selected in the group of: the dialyzer used,the tubing set used, the concentrates used to prepare the dialysisliquid, the vascular access used and size thereof.

In a 54th aspect according to any one of the preceding aspects, thevalues, in one or more embodiments, of the third subgroup of thelaboratory parameters (V_(L)) include values of:

-   -   Urea concentration (pre and/or post treatment session)    -   Creatinine concentration (pre and/or post treatment session)    -   Uric acid concentration (pre and/or post treatment session)    -   Sodium concentration (pre and/or post treatment session)    -   Potassium concentration (pre and/or post treatment session)    -   Bicarbonate concentration (pre and/or post treatment session)    -   Phosphate concentration (pre and/or post treatment session)    -   Calcium concentration (pre and/or post treatment session)    -   Total proteins concentration (pre and/or post treatment session)    -   PTH (parathyroid hormone)    -   Hemoglobin    -   Ferritin    -   Saturation coefficient    -   Albumin    -   CRP (C-reactive protein)    -   Total cholesterol    -   LDL cholesterol    -   Triglycerides    -   Glycemia    -   beta-2-microglobuline    -   Glycated hemoglobin    -   KT/V Urea    -   Systolic and diastolic arterial pressure (TA) measured while        lying on a bed before and after treatment session    -   Weight before and after treatment session.

In a 55th aspect according to any one of the preceding aspects, theindicators may, in one or more embodiments, comprise from 4 to 8 of thefollowing dialysis indicators:

-   -   a first indicator ID₁ relating to the conditions of the vascular        access—this indicator uses a first subclass of the KP_(i)        including one or more of: measured values KPV_(M) for the blood        flow rate, for the ionic dialysance and for the arterial and        venous pressures;    -   a second indicator ID₂ relating to the prescription        conformity—this indicator uses a second subclass of the KP_(i)        including one or more of: prescription values KPV_(S) for the        duration of the treatment, the blood and/or dialysate        conductivity, the blood flow rate, and the patient's dry weight,        and measured values KPV_(M) for the treated blood volume, for        the dialysate conductivity, for the total weight loss and for        the total session duration;    -   a third indicator ID₃ relating to potassium—this indicator uses        a third subclass of the KP_(i) including one or more of:        prescription values KPV_(S) for the dialysate potassium and        laboratory parameter values KPV_(L) for the potassium        concentration in blood;    -   a fourth indicator ID₄ relating to anemia—this indicator uses a        fourth subclass of the KP_(i) including one or more of: measured        values KPV_(M) for hemoglobin and laboratory parameter values        KPV_(L) for hemoglobin, ferritin and saturation coefficient;    -   a fifth indicator ID₅ relating to nutrition and metabolism—this        indicator uses a fifth subclass of the KP_(i) including one or        more of: laboratory parameter values KPV_(L) bicarbonate, blood        sugar, total proteins, albumin, CRP;    -   a sixth indicator ID₆ relating to phosphorous-calcium        equilibrium—this indicator uses a sixth subclass of the KP_(i)        including one or more of: laboratory parameter values KPV_(L)        for phosphate, calcium, PTH;    -   a seventh indicator ID₇ relating to hypertension—this indicator        uses a seventh subclass of the KP_(i) including one or more of:        prescription values KPV_(S) for plasmatic conductivity (initial        and/or final) and for dialysate conductivity; laboratory        parameter values KPV_(L) for sodium concentration in blood        (before and/or after treatment), cardiac parameters (systolic        and diastolic pressure, heart rate), weight before and after        treatment; and measured values V_(M) for dialysate conductivity,        blood conductivity before and after treatment session, ionic        mass transfer, total weight loss, cardiac parameter measures        (systolic and diastolic pressure and heart rate);    -   an eight indicator ID₈ relating to dialysis dose—this indicator        uses an eight subclass of the KP_(i) including one or more of:        laboratory parameter values KPV_(L) for urea and creatinine        concentration in blood pre and post session and for        beta-2-microglobuline and KT/V urea; and measured values V_(M)        for the total treated blood volume and the measured KT and KT/V.

In a 56th aspect according to any one of the preceding aspects, thecontrol unit of each of the client units is, in one or more embodiments,configured to compare each of the values (KPV_(i,k)) taken, over thetime frame T, by the subclasses of selected parameters (KP_(i,k))affecting a same indicator ID_(k) with respective reference criteria andto detect possible drifts compared to what is regarded as a referencecriterion of normality.

In a 57th aspect according to any one of the preceding aspects, thecontrol unit, in one or more embodiments, applies one or more of thefollowing reference criteria in order to classify if the patient'sstatus for each single ID_(k) is acceptable, not acceptable or lies inan area uncertainty:

-   -   for the first indicator ID₁: the ionic dialysance measured        values are compared with a reference; the patient's status is        considered acceptable if the last 3 measures are >than 165        ml/min, not acceptable if the last 3 measures are <than 155        ml/min, and potentially critical in all other cases;    -   for the second indicator ID₂: the status is considered        acceptable if the measured values for the parameters affecting        this indicator are identical or fall within a strict acceptable        range compared to the respective set values;    -   for the third indicator ID₃: the patient's status is considered        acceptable if the last 3 measures for the potassium        concentration in blood are <than 5.5 mmol/l, not acceptable if        the last 3 measures for the potassium concentration in blood        are >than 5.5 mmol/l, and potentially critical in all other        cases;    -   for the fourth indicator ID₄: the patient's status is considered        acceptable if the last 3 values for hemoglobin fall within 10        and 12 g/l; the patient's status is considered not acceptable if        the last 3 values for hemoglobin are either above 13 g/l or        below 10 g/l; the patient's status is considered potentially        critical in all other cases;    -   for the fifth indicator ID₅: the patient's status is considered        acceptable if the following conditions are all met:        -   albumin concentration>32g/l,        -   urea concentration>1.1 g/l,        -   creatinine concentration>60 mg/l,        -   phosphorus concentration>34 mg/l,        -   potassium concentration>4.5 mmol/l;    -   the patient's status is considered not acceptable if the        following conditions are all not met:        -   albumin concentration<32g/l,        -   urea concentration<1.1 g/l,        -   creatinine concentration<60 mg/l,        -   phosphorus concentration<34 mg/l,        -   potassium concentration<4.5 mmol/l;    -   the patient's status is considered potentially critical in all        other cases;    -   for the sixth indicator ID₆: the laboratory values for        phosphorous, calcium and PTH are compared with respective        references; the patient's status is considered acceptable if the        last 3 values for phosphorous lie within 34 and 60 mg/l, and the        last 3 values for calcium lie within 88 and 100 mg/l, and PTH        last value is comprised within 100 and 300 μg/l; the patient's        status is considered not acceptable if the last 3 values for        phosphorous are above 60 mg/l; the situation is considered        potentially critical in all other cases;    -   for the seventh indicator ID₇: the patient's status is        considered not acceptable if the last 3 values for pre-dialysis        session arterial pressure TA are above 170 mm Hg;

the patient's status is considered acceptable if the last 3 values forpre-dialysis session arterial pressure TA are below 150 mm Hg; thepatient's status is considered potentially critical in all other cases;

-   -   for the eight indicator ID₈: the measured KT values are compared        with a reference; the patient status is considered acceptable if        the last 3 measures are >than 40 liters, not acceptable if the        last 3 measures are <than 36 ml/min, and potentially critical in        all other cases. In case of less than 3 measures in the last 15        days, then the assessment is not considered reliable and        discarded.

In a 58th aspect according to any one of the preceding aspects, the timeframe (T) covers, in one or more embodiments, a plurality of bloodtreatment sessions.

In a 59th aspect according to any one of the preceding aspects, the setvalues (V_(S)) of a plurality of prescription parameters include, in oneor more embodiments, one or more in the group of:

-   -   values of a plurality of session parameters set for blood        treatment sessions of each patient over said time frame,    -   values representative of medicament prescriptions which have        been imparted to each patient over said time frame, and    -   values representative of one or more disposable items used        during blood treatment sessions of each patient over said time        frame.

DESCRIPTION OF THE DRAWINGS

The following drawings are provided by way of non limiting example:

FIG. 1 is a schematic illustration of one illustrative embodiment of asystem for monitoring a plurality of patients undergoing extracorporealblood treatment,

FIG. 1A is a schematic illustration of an alternative embodiment of asystem for monitoring a plurality of patients undergoing extracorporealblood treatment,

FIG. 2 is a schematic illustration of one illustrative embodiment of agraphic user interface of a client unit part of the system of FIG. 1 ina first operating mode,

FIGS. 3 and 5 to 10 are schematic illustrations of illustrativeembodiments of a graphic user interface of a client unit part of thesystem of FIG. 1 or 1A in a second operating mode,

FIG. 4 is a schematic illustration of one illustrative embodiment of agraphic user interface of a client unit part of the system of FIG. 1 or1A in a first operating mode with a screen different from that of FIG.2,

FIG. 11 is a schematic illustration of one illustrative embodiment of agraphic user interface of a client unit part of the system of FIG. 1 or1A in a third operating mode;

FIG. 12 shows one exemplary embodiment of a blood treatment machinewhich may be part of the system of FIG. 1 or 1A;

FIG. 13 shows a process of monitoring a plurality of patients undergoingextracorporeal blood treatment; and

FIG. 14 shows another process of monitoring a plurality of patientsundergoing extracorporeal blood treatment.

DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

System

With reference to the appended drawing tables, and particularlyreferring to the illustrative embodiments depicted in FIGS. 1 and 1A,reference numeral 1 and reference numeral 1A respectively indicate asystem which is configured for monitoring a plurality of patientsaffected by kidney failure over a time frame T.

The system 1, 1A comprises a plurality of blood treatment machines 300for the treatment of the monitored patients. In general, each bloodtreatment machine includes at least one respective control unit, such asa CPU 301, actuators 307 and sensors 302, such as by way of non limitingexample: pressure sensors for instance connected to the blood circuit orto the dialysate circuit, conductivity sensors to measure dialysateconductivity, flow meters for detecting the flow rate through thevarious machine lines, temperature sensors and so on. The system 1, 1Acollects data concerning the plurality of monitored patients P: as itwill be explained in detail the collected data concern a plurality ofblood treatment sessions executed by said blood treatment machines 300on the patient(s) as well other data, e.g. coming from sources likelaboratories, hospitals etc.

Each blood treatment machine 300 (an exemplary hemodiafiltration machineis shown in FIG. 12—of course machine 300 may be any machineconfigurable for extracorporeal treatment of blood by ultrafiltration,or hemofiltration, or hemodialysis or hemodiafiltration or other type ofblood treatment) may comprise a blood circuit 310 configured forwithdrawing blood from a patient P and for returning treated blood tothe patient P. The blood circuit includes a blood chamber 311 of a bloodtreatment unit 312 which also presents a dialysate chamber 313 separatedfrom the blood chamber by a semipermeable membrane 314. The dialysatechamber is connected with a fresh dialysate preparation circuit 315 andwith a spent dialysate liquid circuit 316 leading to a waste dischargeend 317. One or more infusion lines 318 may be present and be connectedto the blood circuit, for instance as shown in FIG. 12. Pumps or otheractuators p_(i) (in the example of FIG. 12, p₁ to p₅ represent each arespective pump) may act on the blood circuit, on the infusion line(s)on the fresh dialysate circuit 315 (if present), and on the spent liquidcircuit 316. The specific design of the blood treatment machine is notmaterial to the present invention and therefore it is not furtherdescribed in detail: as a matter of fact, any extracorporeal bloodtreatment machine may be part of the system 1, 1A. In general, sensors302 measure, either continuously or at time intervals, a significantnumber of session parameters which are used to monitor the machineand/or to monitor the patient connected to the blood circuit. Thecontrol unit of each blood treatment machine is configured to receivefrom the sensors 302 signals corresponding to measured values, hereincollectively indicated as V_(M), of a plurality of session parametersmeasured during each blood treatment session for each patient.Typically, the measured values V_(M) are measured during the course ofthe treatment and recorded in a memory 303. V_(M) values may also beacquired via devices 305 distinct but communicatively connected to themachine, such as a pressure detection cuff or an ECG.

In one or more embodiments, the control unit 301 of each blood treatmentmachine is also configured to receive, for instance via a graphic userinterface 304, either at the beginning of the treatment or during thetreatment or before treatment starts, set values V_(S) of a plurality ofprescription parameters which the machine shall observe in the course ofthe treatment. Prescription parameters may include, for example, setvalues of parameters set on said blood treatment machines which themachine should observe during treatment or achieve by the end of thetreatment. The prescription parameters may also include valuesindicative of the disposables used on each session. Furthermore, theprescription parameters may also include values indicative of possiblemedicaments prescribed to patients, i.e. medical prescriptionparameters.

As shown in FIGS. 1, 1A the system 1, 1A may also include one or morelaboratories (by laboratory it is herein meant any center where blood,or other body fluid, may be analyzed to uncover a predetermined numberof properties). Each laboratory comprises or is communicativelyconnected with a lab storage unit 400 or lab database configured tostore values V_(L) of laboratory parameters relating to patient bloodproperties obtained from tests conducted on fluid samples taken fromeach patient. Basically, the laboratory databases include a huge amountof data derived from blood exams conducted on the monitored patientsover time: just to mention some these data may include concentrationsfor a plurality of substances in blood, and various other bloodparameters.

At least one a hub module 200 is, in one or more embodiments, connectedto the blood treatment machines 300 of the system 1, 1A and to thelaboratory storage units 400: the hub module comprises a control unit,such as a control processing unit 203, which is configured tocommunicate directly or indirectly (e.g. via intermediate units whichwill herein after described) with the control units of the bloodtreatment machines and with the processors associated to each laboratorystorage unit in order to receive data both from the blood treatmentmachines and from the laboratory storage units.

More in detail, in the example of FIG. 1 the hub module processing unit,may be configured to receive from said blood treatment machines, and foreach monitored patient, the mentioned values V_(M) of the plurality ofsession parameters measured by the sensors of each blood treatmentmachine during each blood treatment session of each patient over saidtime frame T. Moreover, the hub module processing unit may be configuredto receive from said blood treatment machines and for each monitoredpatient, the set values of V_(S) of prescription parameters set for eachblood treatment session of each patient over said time frame. Inparticular, the hub module processing unit may be configured to receivefrom said blood treatment machines and for each monitored patient, setvalues of V_(S) of prescription parameters comprising one or more in thegroup of:

-   -   values of a plurality of session parameters set for blood        treatment sessions of each patient over said time frame,    -   values representative of one or more disposable items used        during blood treatment sessions of each patient over said time        frame,    -   values representative of medicament prescriptions which have        been imparted to each patient over said time frame (note that        these last values may be transmitted either by a blood treatment        machine or by another unit connected to the system and        communicatively linked to the hub module).

Furthermore, the hub module processing unit may, in one or moreembodiments, be configured to receive from the laboratory storage unitsthe values V_(L) of laboratory parameters obtained from tests conductedon fluid samples taken from each patient over said time frame. As it canbe understood, particularly if a plurality of patients is beingmonitored, the amount of data collected by the hub module is huge,considering the number of dialysis sessions per week each patientnormally receives and the number of blood exams dialysis patientstypically receive on a periodic basis. In one or more embodiments, thehub module control unit 203 is configured to create a key parameter log202 where a selection of all data collected by the hub module is stored.In detail, the key parameter log stores values KPV_(i) of selectedparameters KP_(i)comprising:

-   -   values of a first subgroup of said plurality of session        parameters V_(M),    -   set values of a second subgroup of said plurality of        prescription parameters V_(S), and    -   values of a third subgroup of said plurality of laboratory        parameters V_(L).

In the alternative embodiment of FIG. 1A, the hub module is, in one ormore embodiments, configured to communicate directly or indirectly(e.g., via intermediate units which will herein after described) withthe control units of the blood treatment machines and with theprocessors associated to each laboratory storage unit in order toexclusively receive the values KPV, of selected parameters KP,comprising:

-   -   values of a first subgroup of said plurality of session        parameters V_(M),    -   set values of a second subgroup of said plurality of        prescription parameters V_(S), and    -   values of a third subgroup of said plurality of laboratory        parameters V_(L).

In other words, either the hub module control unit (FIG. 1) receives, inone or more embodiments, all collected values V and makes a selection atthe hub module to create the log 202, or the hub module control unit(FIG. 1A) is configured to receive only a selection of the data andstore them in the hub memory 201. According to further alternatives, thehub module may, in one or more embodiments, be configured to:

-   -   receive all values for V_(M) values and only the KPV_(I) values        for V_(S) and V_(L) values;    -   receive all values for V_(S) values and only the KPV_(I) values        for V_(M) and V_(L) values;    -   receive all values for V_(L) values and only the KPV_(I) values        for V_(S) and V_(M) values;    -   receive all values for V_(M) and Vs values and only the KPV_(I)        values for V_(L) values;    -   receive all values for V_(L) and Vs values and only the KPV_(I)        values for V_(M) values;    -   receive all values for V_(M) and V_(L) values and only the        KPV_(I) values for V_(S) values.

According to one embodiment, the values of the first subgroup of saidplurality of session parameters V_(M), and may include measured valuesfor one or more of the following parameters:

-   -   blood flow rate,    -   clearance or dialysance values,    -   treated blood volume,    -   K*Tr and or K*Tr/V where K is measured dialysance, Tr is        treatment time and V a reference volume,    -   dialysate conductivity,    -   patient blood conductivity at the beginning and/or at the end of        the treatment session,    -   transferred ionic mass,    -   total weight loss,    -   real session duration,    -   measures of cardiac parameters: systolic and diastolic arterial        pressure (TA), cardiac rate,    -   arterial and/or venous pressure,    -   hemoglobin, e.g. obtained by calorimetric detection.

The set values of the second subgroup of said plurality of prescriptionparameters V_(S) may, in one or more embodiments, include for each bloodtreatment session of each patient over said time frame T one or more ofthe following:

-   -   duration of the blood treatment session,    -   blood or dialysate conductivity,    -   blood flow rate,    -   patient's dry weight,    -   the calcium concentration for the dialysis liquid,    -   the potassium concentration for the dialysis liquid,    -   the blood flow rate in the extracorporeal circuit,    -   the weight loss rate,    -   the total weight loss to be achieved at the end of the        treatment,    -   the blood conductivity to be achieved at the end of the        treatment,    -   the dialysis dose.

The prescription parameters may also, in one or more embodiments,indicate the disposables used on each session, including valuesindicative for instance of: the dialyzer used, the tubing set used, theconcentrates used to prepare the dialysis liquid, the vascular accessused and size thereof, etc.

Finally, the values of the third subgroup of the laboratory parametersV_(L) may, in one or more embodiments, include values of:

-   -   Urea concentration (pre and/or post treatment session)    -   Creatinine concentration (pre and/or post treatment session)    -   Uric acid concentration (pre and/or post treatment session)    -   Sodium concentration (pre and/or post treatment session)    -   Potassium concentration (pre and/or post treatment session)    -   Bicarbonate concentration (pre and/or post treatment session)    -   Phosphate concentration (pre and/or post treatment session)    -   Calcium concentration (pre and/or post treatment session)    -   Total proteins concentration (pre and/or post treatment session)    -   PTH    -   Hemoglobin    -   Ferritin    -   Saturation coefficient    -   Albumin    -   CRP    -   Total cholesterol    -   LDL cholesterol    -   Triglycerides    -   Glycemia    -   beta-2-microglobuline    -   Glycated hemoglobin    -   KT/V Urea    -   Systolic and diastolic arterial pressure (TA), before and after        treatment session    -   Heart rate    -   Weight before and after treatment session.

In other words, the log file 202, or in the case of FIG. 1A the KPV_(i)values in memory 201, include, in one or more embodiments, an extremelyreduced amount of data compared to the collected values V_(S), V_(M) andV_(L).

As shown in FIGS. 1 and 1A, the system 1, 1A also includes, in one ormore embodiments, a plurality of client units 100 each configured forreading the data coming from the key parameter log 202 and/or memory201. The client unit may, in one or more embodiments, be a portabledevice (such as, e.g., a hand held unit, a laptop, a palmtop, or may beincorporated into a mobile telephone) or may be a fixed unit such as aPC or other unit able to elaborate and display information. The data ofthe key parameter log of FIG. 1 or in the memory 201 of FIG. 1A may, inone or more embodiments, be copied on a transfer memory which is movedto and read by each client unit: alternatively, the client unit may, inone or more embodiments, be capable of remotely communicating with thehub module, as detailed herein below.

For instance, each or a number of the client units may, in one or moreembodiments, be further configured for interrogating at time intervals(t), for instance at regular time intervals, the hub module andreceiving updated values KPV_(i) of the selected parameters KP_(i)contained in the key parameter log 202 or in memory 201. Alternatively,the hub module may, in one or more embodiments, be configured todispatch at time intervals a copy of the key parameter values KPV_(i) toeach client unit. In order to establish remote communication anysuitable carrier may be used, e.g.: the World Wide Web, a dedicated dataline, a radio connection, or combinations thereof. In both cases, thehub module processing unit is configured to either transmit or toprepare for transmission to the client units the values KPV_(i) of theselected parameters KP_(i) contained in the key parameter log 202(FIG. 1) or in the memory 202 (FIG. 1A).

As shown in FIGS. 1 and 1A, the system may, in one or more embodiments,include an intermediate elaborating unit 500 and/or a furtherintermediate unit 501. If present, the intermediate unit 500 iscommunicatively interposed between the hub module 200 and some or allthe blood treatment machines: in this case, the intermediate unit 500may work as an intermediate collector for the values V_(S) and V_(M)coming from a number of blood treatment apparatus. Note that certainV_(S) values may also be collected by the intermediate unit 500 viaother sources, particularly if the V_(S) values relating to drugprescriptions to patients. The intermediate unit 500 may then, in one ormore embodiments, be configured to transmit either periodically or uponhub module request or upon detection of a command, the collected valuesto the hub module.

If present, the further intermediate unit 501 is, in one or moreembodiments, communicatively interposed between the hub module 200 andsome or all the laboratory databases: in this case the furtherintermediate unit 501 may work as an intermediate collector for thevalues V_(L) coming from a number of laboratory databases. The furtherintermediate unit 501 may then be configured to transmit, in one or moreembodiments, either periodically or upon hub module request or upondetection of a command the collected values to the hub module.

The Client Units

Each client unit 100 comprises, in one or more embodiments, at least onerespective control unit (such as CPU 103) configured to store, for eachpatient, the values KPV_(i) of the selected parameters KP_(i) containedin the key parameter log 202 (FIG. 1) or in the memory 201 (FIG. 1A).The control unit 103 is, in one or more embodiments, further configuredto define, for each of said patients, a number of indicators ID_(k)wherein each of said indicator is distinct from the other and is definedbased on the values KPV_(i,k) taken by a respective subclass KP_(i,k) ofsaid selected parameters KP_(i).

Each indicator is designed to provide the operator with information,(e.g., clear and immediate information) on the status of a key aspect ofthe dialysis treatment delivered to a specific patient. In accordancewith one or more embodiments, up to eight (8) dialysis indicators ID_(k)may be defined by each control unit or CPU 103, as follows:

-   -   a first indicator ID₁ relating to the conditions of the vascular        access—this indicator may, in one or more embodiments, use a        first subclass of the KP_(i) including: measured values KPV_(M)        for the blood flow rate, for the ionic dialysance and for the        arterial and venous pressures;    -   a second indicator ID₂ relating to the prescription        conformity—this indicator may, in one or more embodiments, use a        second subclass of the KP_(i) including: prescription values        KPV_(S) for the duration of the treatment, the blood and/or        dialysate conductivity, the blood flow rate, and the patient's        dry weight, and measured values KPV_(M) for the treated blood        volume, for the dialysate conductivity, for the total weight        loss and for the total session duration;    -   a third indicator ID₃ relating to potassium—this indicator may,        in one or more embodiments, use a third subclass of the KP_(i)        including: prescription values KPV_(S) for the dialysate        potassium and laboratory parameter values KPV_(L) for the        potassium concentration in blood;    -   a fourth indicator ID₄ relating to anemia—this indicator may, in        one or more embodiments, use a fourth subclass of the KP_(i)        including: measured values KPV_(M) for hemoglobin and laboratory        parameter values KPV_(L) for hemoglobin, ferritin and saturation        coefficient;    -   a fifth indicator ID₅ relating to nutrition and metabolism—this        indicator may, in one or more embodiments, use a fifth subclass        of the KP_(i) including: laboratory parameter values KPV_(L)        bicarbonate, blood sugar, total proteins, albumin, CRP;    -   a sixth indicator ID₆ relating to phosphorous-calcium        equilibrium—this indicator may, in one or more embodiments, use        a sixth subclass of the KP_(i) including: laboratory parameter        values KPV_(L) for phosphate, calcium, PTH;    -   a seventh indicator ID₇ relating to hypertension—this indicator        may, in one or more embodiments, use a seventh subclass of the        KP_(i)including: prescription values KPV_(S) for plasmatic        conductivity (initial and/or final) and for dialysate        conductivity; laboratory parameter values KPV_(L) for sodium        concentration in blood (before and/or after treatment), cardiac        parameters (systolic and diastolic pressure, heart rate), weight        before and after treatment; and measured values V_(M) for        dialysate conductivity, blood conductivity before and after        treatment session, ionic mass transfer, total weight loss,        cardiac parameter measures (systolic and diastolic pressure and        heart rate);    -   an eighth indicator ID₈ relating to dialysis dose—this indicator        may, in one or more embodiments, use an eighth subclass of the        KP_(i) including: laboratory parameter values KPV_(L) for urea        and creatinine concentration in blood pre and post session and        for beta-2-microglobuline and KT/V urea; and measured values        V_(M) for the total treated blood volume and the measured KT and        KT/V.

In one or more embodiments, each of the values KPV_(i,k) taken, over thetime frame T, by the subclasses of selected parameters KP_(i,k)affecting a same indicator ID_(k) may be compared with respectivereference criteria in order to detect possible drifts compared to whatis regarded as normality.

For instance, referring to the above eight indicators ID_(k) the controlunit may, in one or more embodiments, be configured to apply thefollowing reference criteria in order to classify if the patient'sstatus for each single ID_(k) is acceptable, not acceptable or lies inan area uncertainty (potentially critical):

-   -   for the first indicator ID₁: the ionic dialysance measured        values are compared with a reference; the patient's status is        considered acceptable, in one or more embodiments, if, e.g., the        last 3 measures are greater than 165 ml/min, not acceptable if,        e.g., the last 3 measures are less than 155 ml/min, and        potentially critical in all other cases. In case of, e.g., less        than 3 measures in the last 15 days, then the assessment is, in        one or more embodiments, not considered reliable and discarded;    -   for the second indicator ID₂: the status is considered        acceptable if, in one or more embodiments, all the measured        values (e.g. treated blood volume, dialysate conductivity, total        weight loss and total treatment time) are identical or fall        within a strict acceptable range compared to the respective set        values;    -   for the third indicator ID₃: the patient's status is, in one or        more embodiments, considered acceptable if the last 3 measures        for the potassium concentration in blood are, e.g., less than        5.5 mmol/l, not acceptable if, e.g., the last 3 measures for the        potassium concentration in blood are greater than 5.5 mmol/l,        and potentially critical in all other cases;    -   for the fourth indicator ID₄: the patient's status is, in one or        more embodiments, considered acceptable if the last 3 values for        hemoglobin fall within, e.g., 10 and 12 g/l; the patient's        status is considered not acceptable if the last 3 values for        hemoglobin are either above, e.g., 13 g/l or below, e.g., 10        g/l; the patient's status is considered potentially critical in        all other cases;    -   for the fifth indicator ID₅: the patient's status is, in one or        more embodiments, considered acceptable if the following        conditions are all met:        -   albumin concentration>32g/l,        -   urea concentration>1.1 g/l,        -   creatinine concentration>60 mg/l,        -   phosphorus concentration>34 mg/l,        -   potassium concentration>4.5 mmol/l;    -   the patient's status is considered not acceptable if the        following conditions are all not met:        -   albumin concentration<32g/l,        -   urea concentration<1.1 g/l,        -   creatinine concentration<60 mg/l,        -   phosphorus concentration<34 mg/l,        -   potassium concentration<4.5 mmol/l;    -   the patient's status is considered potentially critical in all        other cases;    -   for the sixth indicator ID₆: the laboratory values for        phosphorous, calcium and PTH are compared with respective        references; the patient's status is, in one or more embodiments,        considered acceptable if the last 3 values for phosphorous lie        within, e.g., 34 and 60 mg/l, and the last 3 values for calcium        lie within, e.g., 88 and 100 mg/l, and PTH last value is        comprised within, e.g., 100 and 300 μg/l; the patient's status        is considered not acceptable if the last 3 values for        phosphorous are above, e.g., 60 mg/l; the situation is        considered potentially critical in all other cases;    -   for the seventh indicator ID₇: the patient's status is, in one        or more embodiments, considered not acceptable if the last 3        values for pre-dialysis session arterial pressure TA are above,        e.g., 170 mm Hg; the patient's status is considered acceptable        if the last 3 values for pre-dialysis session arterial pressure        TA are below, e.g., 150 mm Hg; the patient's status is        considered potentially critical in all other cases;    -   for the eight indicator ID₈: the measured KT values are compared        with a reference; the patient status is, in one or more        embodiments, considered acceptable if the last 3 measures are,        e.g., greater than 40 liters, not acceptable if the last 3        measures are, e.g., less than 36 ml/min, and potentially        critical in all other cases. In case of less than 3 measures in        the last 15 days, then the assessment is, in one or more        embodiments, not considered reliable and discarded.

Although above criteria may have slight variations depending upon theimplementation, it should be noted that there exist, in one or moreembodiments, a plurality of dialysis indicators having acceptancecriteria using—at the same time values of a plurality of parameters—toestablish whether a patient's status is acceptable or not.

The control unit or CPU 103 may, in one or more embodiments, beconfigured to signal whether one or more of said criteria are met ornot; in practice the control unit may be programmed to issue a warningsignal for activating an alarm in case of drift of one or moreindicators from respective normality criteria (acceptable); the alarmmay be acoustic or visual: depending on the type of alarm the controlunit shall cooperate with corresponding visual actuators (such asspeakers or buzzers) or acoustic actuators (such as dedicated lamps orparts of the display of the GUI conveniently activated by the controlunit); the control unit 101 may also, in one or more embodiments, beconfigured to indicate, via a user interface, whether each criterion isnon-acceptable or only potentially susceptible of being problematic, asit will be described herein below.

Going back to FIGS. 1 and 1A, each client unit 100 is, in one or moreembodiments, an apparatus comprising a memory 101, a graphic userinterface 102 and a control unit 103 connected to the memory and tographic user interface. As already shortly described, each client unit100 is, in one or more embodiments, configured for receiving andinterpreting data (the KPV_(i)) contained in the key parameter log 202or in the memory 201 of the above described hub module. In furtherdetail, the control unit 103 may, in one or more embodiments, beconfigured to receive and store in the client unit memory 101, for eachpatient P, the values KPV_(i) contained in the key parameter log 202,and define, for each of said patients, the plurality of distinctdialysis indicators ID_(k) wherein each of said indicator is definedbased on the values KPV_(i,k) taken by a respective subclass KP_(i,k) ofsaid selected parameters KP_(i).

With reference to FIGS. from 2 to 10, the control unit government of thegraphic user interface 102 so as to provide the user with a toolconsolidating only relevant information and in an easy to use andcomprehend manner is, in one or more embodiments, described. Withreference to FIG. 2, it can be seen that the control unit 103 may, inone or more embodiments, be configured to operate in a first displaymode: in this first display mode the control unit generates on thegraphic user interface 102 a first display 110 comprising, in one ormore embodiments, a first selection tool 111 (for instance in the formof a drop down menu) for choosing one among the selected parametersKP_(i). The control unit also, in one or more embodiments, displays afirst display field 112 showing, for each of a plurality of patients, arespective graphic representation 113 (for instance in the form of avertical bar) of one or more significant values taken by the chosenparameter across said time frame (T); in the example of FIG. 2 the firstselection tool is a drop down menu which elements may be selected usinga pointer, such as, e.g., a mouse-controlled or key-board controlledpointer, or directly touching the selection area if the graphic userinterface is presented on a touch screen. The first display field may,in one or more embodiments, be substantially rectangular and may occupythe major part of the visual area of the GUI; moreover, the firstdisplay field 112 may comprise a Cartesian representation where one axis115 represents the patients and one other axis 116 represents themeasure of the values taken by the selected parameters KP_(i). In theexample of FIG. 2, each first graphic representation 113 comprises, inone or more embodiments, a representation (e.g. a point 113 a)indicative of the mean value taken by the selected parameter across saidtime frame (T) and a graphic representation (e.g. a bar 113 b)indicative of the distribution of values taken by the selected parameteraround said mean value. The bar 113 b in FIG. 2 represents thedistribution of a certain percentage (e.g., 80%) of the values aroundthe mean value, while a segment 113 c, vertically longer than the bar,indicates the maximum and minimum values for the KP_(i) selected withthe selection tool 111 (in FIG. 1 blood flow is the selected KP_(i)).

As shown in FIG. 3, the control unit is, in one or more embodiments,also configured for switching to a second display mode: in this secondmode the control unit 103 is, in one or more embodiments, configured togenerate on said graphic user interface 102 a second display 120comprising a second selection tool 121 for choosing one among theindicators ID_(k). The second selection tool 121 may comprise aplurality of selectable zones 128 (in the case shown in the figures,there are eight (8) indicators and, therefore, eight (8) possibleselection zones in tool 121): each of said selectable zones correspondsto a respective one of said indicators ID_(k). For instance, theselectable zones 128 may, in one or more embodiments, be displayed inside by side relation to define a navigation bar. The control unit 103may, in one or more embodiments, be configured to detect selection ofone indicator by detecting selection of the corresponding selectablezone 128, and display on the second display field 122 of second display120 the graphic representations 123 of the values KPV_(i,k) taken, overthe time frame T, by the subclass of said selected parameters KP_(i,k)affecting the selected indicator ID_(k) and relating to the chosenpatient (as selected in the first display mode). For instance, in FIG.3, the selected indicator in tool 121 is ‘vascular access’ and thevalues KPV_(i,k) of KP_(i,k) affecting indicator ‘vascular access’ aredialysance, blood flow and arterial and venous pressure which arepresented in a Cartesian representation where the X-axis 125 representstime and the Y-axis 126 represents the value KPV_(i,k). Depending uponthe case, the second display field may include, e.g., two or moreseparate display areas: display areas 122 a and 122 b are for instancevisible in FIG. 3, while the second display includes display areas 122a, 122 b and 122 c in FIG. 9; each display area is, e.g., used fordisplaying values measurable with a same unit: in the case of FIG. 3,pressures are in displayed area 122 b while dialysance and blood flowrate are in display area 122 a.

FIGS. 5 to 10 are analogous to FIG. 3 and represent the second displayfields which the control unit is, in one or more embodiments, configuredto display upon selection of the respective item in the selection tool121.

In one or more embodiments, the control unit in said first display modemay be configured to allow choosing one patient and to detect selectionof said one patient. As a consequence of detecting selection of onepatient, the control unit is, in one or more embodiments, configured toactivate the second display mode thus displaying the second display onthe graphic user interface. In the second display mode, the control unitdisplays, in one or more embodiments, the graphic representations 123 ofthe values KPV_(i,k) taken, over the time frame T, by the subclass ofthe selected parameters KP_(i,k) affecting the selected indicator ID_(k)and relating to the chosen patient. In practice, while in the firstdisplay mode the user is in condition to select the patient and to causeswitching to the second display mode: then when in the second displaymode a detection is made of the selected item in selection tool 121 andthus the corresponding values KPV_(i,k) are displayed; note that in theexample shown, the control unit 103 is configured to hide the firstdisplay 110 when the second display mode is activated.

Going into further detail, the control unit 103 may, in one or moreembodiments, be configured to display the representations 113 in side byside relation in said first display field 112 and to detect the patientchosen by detecting selection of one of said first graphicrepresentations 113. The selection may occur in various alternativeways, e.g., by detecting overlapping of a graphic selector 114 with thechosen one among said first graphic representations; the graphicselector 114 may be any item graphically differentiating the chosenfirst graphic representation from the other first graphicrepresentations displayed on the first display. Alternatively, when thegraphic user interface 102 comprises a touch screen, then detectingselection of one graphic representation 113 may comprise detectingtouching of a touch screen area where the graphic representation 113 isdisplayed. Note that the switch to the second display mode may occurautomatically upon patient selection or after detecting entry of aconfirmation (such as a pressing a further soft or hard confirmation keypart of the user interface) indicative that the user really intends toswitch to the second display mode. In addition or as a furtheralternative, the control unit 103 may, in one or more embodiments, beconfigured to display a menu area 130, e.g. in the form of a menu bar,comprising a plurality of selectable areas including, e.g., a firstselectable area 131 and a second selectable area 132 and an optionalthird selectable area 133. The control unit may, in one or moreembodiments, be programmed to detect selection of the first selectablearea and to activate the first display mode when the first selectablearea is selected and to detect selection of the second selectable area132 and to activate the second display mode when the second selectablearea is selected. In other words, the bar 130 would, e.g., work as anavigation bar across display modes: when switching to the second modethe selected patient and selected indicator are taken into account forthe purpose of displaying the proper data. Note that in the exampleshown in the appended figures, the control unit 103 is, in one or moreembodiments, configured to display the menu area 130 both in said firstand in said second display modes and to graphically differentiate thefirst and second selectable areas respectively when the first or thesecond display mode is activated to provide a user with a graphicindication of which mode is active.

In one or more embodiments, the control unit 103 (see FIG. 4), when insaid first display mode, may be configured to display on said graphicuser interface an auxiliary display 160 comprising a table 161displaying a list 162 of the monitored patients, the control unit beingalso configured to associate an identification code to each patient andto detect the patient chosen by detecting selection of the respectiveidentification code. Moreover, the auxiliary display 160 may, in one ormore embodiments, have a recap format comprising a table 161 (againrefer to FIG. 4) displaying a list 162 of monitored patients, a list 163of said indicators ID_(k), and a score 164 associated to a number ofindicators and patients. Each of the displayed scores is, in one or moreembodiments, univocally associated to a respective patient and to arespective indicator ID_(K) and depends upon the outcome of the abovedescribed acceptance criteria for each dialysis indicator: the controlunit may also be configured to calculate each one of said scores 164based on a comparison of each of the values KPV_(i,k) taken, for therespective patient, by the subclass of said selected parameters KP_(i,k)affecting the indicator ID_(k), with a respective reference criterion asdescribed for the 8 indicators above. In practice a first score (e.g.,zero) may, in one or more embodiments, be associated in case theacceptance criteria is met, a second score (e.g.: two) may be associatedif a certain criterion is not met, and an intermediate score (e.g.: one)in all other situations. The control unit may, in one or moreembodiments, be configured to associate a respective graphicrepresentation to each score: for instance, each code may have adifferent background texture, color or a different size, depending uponthe score value. In the example shown in FIG. 4, a green backgroundcolor may be associated to a score=0 (meaning an acceptable condition),a yellow background color to a score=1 (meaning an intermediatesituation) and a red background color to a score=2 (meaning anon-acceptable condition).

As it is shown in FIG. 4, the control unit may, in one or moreembodiments, also be configured to calculate the sum and/or a mean valueof the scores 164 for each monitored patient. Furthermore, the controlunit may, in one or more embodiments, be configured to display the sumof scores 164 and/or to rank the patients from the one having highestscore and thus highest risk of being problematic, to the one havinglowest score, thus serving as a tool to drive operator (medical doctoror nurse) attention to those patients in the population of monitoredpatients really deserving immediate attention.

Going in further detail and again referring to FIG. 4, the control unitmay, in one or more embodiments, be configured—when in said firstdisplay mode—to display a switching tool 170 for alternatively switchingamong and displaying one of the first display, the auxiliary display andthe auxiliary display in recap format. In the embodiment shown, theswitching tool 170 is represented by three selectable keys or buttons.

In one or more embodiments, the control unit 103 of each client 100 maybe configured to allow setting of said time frame T to display, e.g. insaid first display mode, a time frame selection tool 170 allowing to setat least one of: a start of said time frame (T), an end of said timeframe (T), or both a start and an end of said time frame T.

The control unit 103 may, in one or more embodiments, also be configuredto allow setting of a number of population filtration criteria and/or tostore in said memory a plurality of pre-confectioned populationfiltration criteria. In both cases, the control unit may be configuredto display in said first display mode a population filtration tool 180for the setting of one population filtration criterion, detect thesetting of a population filtration criterion and allow choosing onepatient only among those satisfying the set population filtrationcriterion.

Note that in one or more embodiments, the population filtration criteriamay be or include a condition concerning one or more of the valuesKPV_(i) of selected the parameters KP_(i). Alternatively, the populationfiltration criteria comprise conditions concerning one or more of saidindicators ID_(k). For instance, as acceptance criteria have been fixedfor each indicator, a population filtration criterion may allowselecting patients within the monitored population which have a certainnumber of indicators not meeting the acceptability criteria. Inaccordance with a further alternative, the population filtrationcriteria may be based on the scores or on the mean value (as abovedescribed) of the scores: in other words, patients with a scoresatisfying a certain rule (e.g. a score mean value higher than a certainthreshold) may be selected and data thereof allowed to be displayed.

Furthermore, in accordance with one or more embodiments, filtrationcriteria may concern the indicators: for instance an operator may beallowed to chose one or more indicators ID_(k) of interest, and theclient units receive and store in the apparatus memory 101, for eachpatient P, only the values KPV_(i) contained in the hub module memory201 taken, over the time frame T, by the subclass of said selectedparameters KP_(i,k) affecting the chosen indicators ID_(k). Thisprovision may help to focus on selected indicators only and to therebytransfer and elaborate only a reduced amount of data. The above criteriamay also be combined: for instance the control unit may, in one or moreembodiments, be configured to retain in the memory 101 and then use onlydata concerning a selected number of indicators and in particular onlydata concerning those patients having indicators falling out of therespective acceptability criteria, for the user to have the possibilityto examine only potentially problematic patients and indicators.

Note that although in the present description the filtration criteriaare executed by each control unit after transfer of the data from thehub module to client units, it may alternatively be envisaged thatfiltration criteria may, in one or more embodiments, be applied at thehub module before transferring data to each client unit 100.

Finally, in accordance with one or more embodiments, each client unitmay also operate in a third display mode (see FIG. 11). Indeed, thecontrol unit 103 may be configured to allow, when in said second displaymode, a choice of one among the values taken by the parameters of saidsubclass of selected parameters KP_(i,k) affecting the selectedindicator ID_(k). For instance referring to FIG. 3, the control unit 103may allow selection of one of the values 123, for instance a value ofthe extracorporeal blood flow rate or of the dialysance; note that inthe second display mode each value 123 relates to a single patient,namely the patient selected before switching from the first to thesecond mode. Selection of the value 123 may be done as above describedin connection with selection of the graphic representations 113 in thefirst display mode and, for this reason, it is not repeated. Then thecontrol unit establishes the treatment session corresponding to thechosen value 123 and to the chosen patient and, in one or moreembodiments, activates the third display mode, comprising generating athird display 140 on said graphic user interface 102 having a thirddisplay field 142 showing, for the chosen patient and for the treatmentsession corresponding to the chosen value 123, a respective graphicrepresentation 143 of plurality of values (for instance in table format)taken at different instants over session treatment time by a pluralityparameters characteristic of a treatment session (e.g. time,extracorporeal blood flow rate Q_(B), dialysance D_(Y), plasmaticpatient conductivity C_(P), dialysate conductivity C_(D), arterial andvenous pressures P_(A) and P_(V), systolic and/or diastolic pressure,heart rate HR, blood volume, volume of treated blood and so on.

Connectivity

The control unit 103 may, in one or more embodiments, be configured toreceive a copy of the information contained in the key parameter log orin memory 201 in various manners.

In one example, the control unit may remotely connect with the hubmodule and receive, at time intervals, the values KPV_(i) of selectedparameters KP_(i) contained in a key parameter log 202 or in memory 201.For instance the control unit may, in one or more embodiments, beconfigured to interrogate the hub module at a plurality of regular timeintervals during said time frame T in order to collect a plurality ofsets of values KPV_(i) of selected parameters KP_(i), and thereby updatethe information displayed in the first and second display modesaccordingly. In this case the control unit may include or be providedwith a clock generator 103 a for generating the interrogation times atwhich the control unit shall interrogate the hub module by generating aninterrogation signal. Moreover, the control unit may be connected with amodem circuit 103 b and with either an antenna 103 c or with a wiredconnection for sending the interrogation signal to the hub module.Alternatively, the hub module may, in one or more embodiments, send afile or a number of files containing a copy of the content of the keyparameter log 202 or a copy of the relevant data in memory 201 to eachor to a number of client units via any available transmission channel:radiofrequency, World Wide Web, dedicated physical line and so on.

In a further alternative, the content of the key parameter log 202 or ofmemory 201 may, in one or more embodiments, be stored in a memorysupport, such a memory stick or a disk or a memory chip, which is thenshipped to each client unit.

Furthermore, from a structural point of view it should be noted that, inone or more embodiments, hub module may be an independent hardware unitremotely located and communicatively connected with the blood treatmentunits and with the database units. In order to establish communication,the client units may, in one or more embodiments, include a modem deviceconnected to the control unit and to an antenna for wireless connectionor to a cable for wired connection with the hub module. On its turn, thehub module may, in one or more embodiments, be provided with arespective modem and with an antenna and or with a cable connection withunits remote to the hub module.

In case one or two intermediate units are present, these intermediateunits may, in one or more embodiments, also be independent hardwareunits remotely connected to the hub module and to the blood treatmentunits and/or laboratory database units. In such a case, also theintermediate units include a respective modem and an antenna or a cableconnection for communicating with the other units of the systems 1, 1A.

In one alternative, however the hub module could, in one or moreembodiments, be part of the intermediate unit 500 or of the furtherintermediate unit 501.

Process

One or more embodiments of a process of monitoring a plurality ofpatients over a time frame covering a plurality of blood treatmentsessions are now described. The process may use the system comprising,in one or more embodiments, a plurality of client units, a hub module,laboratory databases and a plurality of blood treatment machines andoptionally one or more intermediate units as above described. Theprocess, in one or more embodiments, comprises collecting values V of ahuge number of patient parameters (step 600 in FIGS. 13 and 14) and thenexecution of a number of steps at the hub module and at each client unitremotely located from the hub module. The collected values are then, inone or more embodiments, transmitted to the hub module (step 700), e.g.by the blood treatment machines and/or by one or more of the laboratorydatabases and/or by one or both the intermediate units 500 and 501.

According to a first alternative shown in FIG. 13, the hub module 200remotely connected to the blood treatment machines 300 and to laboratorystorage units 400, executes, in one or more embodiments, the followingprocess steps:

-   -   receiving (step 700) for each one of the plurality of patients,        values V taken by a plurality of patient parameters at different        time instants during the time frame T; the values of the        plurality of patient parameters include, in one or more        embodiments, for each patient:    -   values V_(M) of a plurality of session parameters measured by        sensors of blood treatment machines 300 during each blood        treatment session of each patient over said time frame,    -   values V_(L) of a plurality of laboratory parameters obtained        from tests conducted on fluid samples taken from each patient        over said time frame T and stored in one or more laboratory        storage units 400,    -   set values V_(S) of a plurality of prescription parameters set        for each blood treatment session and each patient on each of        said blood treatment machines 300 over said time frame,

-   creating a key parameter log 202 (step 701) for storing the values    KPV, of selected parameters KP_(i), wherein creating, in one or more    embodiments, comprises:    -   selecting (step 702) a first subgroup comprising, for each        monitored patient, values of a selection of the plurality of        session parameters V_(M),    -   selecting (step 702) a second subgroup comprising, for each        monitored patient, set values of a selection of the plurality of        prescription parameters V_(S),    -   selecting (step 702) a third subgroup comprising, for each        monitored patient, values of a selection the plurality of        laboratory parameters V_(L), and    -   storing (step 703) the selected key parameters values KPV_(i).

The process then provides, in one or more embodiments, for a step oftransmitting (step 704 a) all or a subportion of the selected keyparameters values KPV_(i) and a step of receiving all or a subportion ofthe selected key parameters values KPV_(i) at the client unit(s). As itis shown in FIG. 13, before transmitting the key parameter values, astep 705 of verifying one or more population filtration criteria may becarried out and then, in one or more embodiments, transmitting (step 704a) only those key parameter values concerning those patients satisfyingthe filtration criterion or criteria applied in step 705. In accordancewith one or more embodiments, the population filtration criteria may beor include a condition concerning one or more of the values KPV_(i) ofselected the parameters KP_(i). Alternatively, the population filtrationcriteria may, in one or more embodiments, comprise conditions concerningone or more of said indicators ID_(k). For instance as acceptancecriteria have been fixed for each indicator, then a populationfiltration criteria may be that of selecting patients among thepopulation which have a certain number of indicators not meeting theacceptability criteria. In accordance with one or more furtheralternative embodiments, the population filtration criteria may be basedon the scores or on the mean value of the scores. Note that instead ofor in addition to population filtration criteria, the filtrationcriteria may, in one or more embodiments, relate to the indicatorsID_(k): for instance, for each patient P, only the values KPV_(i) taken,over the time frame T, by the subclass of said selected parametersKP_(i,k) affecting chosen indicators ID_(k) may be transferred to theclient units. This provision may help to focus on selected indicatorsonly and to thereby transfer and elaborate only a reduced amount ofdata.

Alternatively, to what shown in FIG. 13, the filtration criterion orcriteria may, in one or more embodiments, be applied after transfer ofall key parameter values to the client units, i.e. after steps 704 a and704 b takes place. In this case, the filtration criteria are executed bythe client units.

As shown in FIG. 13, the following further process steps are, in one ormore embodiments, executed at each of the client units:

-   -   defining, for each of said patients, a number of indicators        ID_(k) (step 706) wherein each of said indicator is distinct        from the other and is defined based on the values KPV_(i,k)        taken by a respective sub-group KP_(i,k) of said plurality of        patient parameters KP_(i) (the step of defining may, in one or        more embodiments, alternatively be executed at the hub module);    -   assessing if the indicators (or a number of indicators) satisfy        certain respective reference criteria (step 707); for example,        this may be done by comparing values KPV_(i,k) taken, over the        time frame T, by the subclasses of selected parameters KP_(i,k)        affecting a same indicator ID_(k) with the respective reference        criteria (please refer to the section ‘client units’ for        exemplifying reference criteria applicable to each of eight (8)        indicators),    -   signaling (708) whether or not one or more of said criteria are        met.

At client units 100, the process may also or alternatively comprise, inone or more embodiments, execution of the following steps:

-   -   generating the first and second display modes (steps 709 and        710) and    -   allowing switching between the two display modes.

At the client units, the process may also comprise, in one or moreembodiments, generating a third display mode (step 711) which may beactivated from the second display. The generation and switching amongdisplay modes, as well the features included in each display mode,correspond to what described in the above section ‘client units’ andthus are not further described in this section.

In the alternative process shown in FIG. 14, a step of collection ofvalues V (step 600) as described for the process of FIG. 13 is providedin one or more embodiments. In detail, step 600 comprises collecting,for each one of the plurality of patients, values V taken by a pluralityof patient parameters at different time instants during the time frameT; the values of the plurality of patient parameters include, in one ormore embodiments, for each patient:

-   -   values V_(M) of a plurality of session parameters measured by        sensors of a blood treatment machine 300 during each blood        treatment session of each patient over said time frame,    -   values V_(L) of a plurality of laboratory parameters obtained        from tests conducted on fluid samples taken from each patient        over said time frame T and stored in one or more laboratory        storage units 400,    -   set values V_(S) of a plurality of prescription parameters set        for each blood treatment session and each patient on each of        said blood treatment machines 300 over said time frame.

Then, after step 600 and before actually transmitting (step 800 a)collected data to the hub module, a scan is made, in one or moreembodiments, of the collected values V for identifying values KPV_(i) ofselected parameters KP_(i). In particular, the identification comprises:

-   -   selecting (step 802) a first subgroup comprising, for each        monitored patient, values of a selection of the plurality of        session parameters V_(M),    -   selecting (step 802) a second subgroup comprising, for each        monitored patient, set values of a selection of the plurality of        prescription parameters V_(S), and    -   selecting (step 802) a third subgroup comprising, for each        monitored patient, values of a selection the plurality of        laboratory parameters V_(L).

The values KPV_(i) of the selected parameters KP_(i), may be stored, inone or more embodiments, either at one of the intermediate units or atthe machines or at the laboratory databases or in part in one or more ofthe mentioned items (step 803). Then, differently from the process ofFIG. 13, only the identified KPV_(i) values are, in one or moreembodiments, transferred (step 800 a) to and then received at and storedby (step 804 b) the hub module. Thus, according to the process of FIG.14, in one or more embodiments, step 700 is not present and steps 701,702, 703 are not executed at the hub module.

The further steps 705 to 711 of the process of FIG. 14 are analogous tothose of the process of FIG. 13, have been identified by same referencenumerals and not further described to avoid redundancy.

Control Units

In the above description, it has been indicated that, in one or moreembodiments, a respective control or processing unit is located at thehub module, at each remote unit, at each blood treatment unit and ateach laboratory database unit. From an architectural point of view, eachof these units may, in one or more embodiments, comprise one or moreprogrammable microprocessors or an analog type of control circuit or acombination thereof. In the case where the hub module is physicallyintegrated into the intermediate unit 500 or into the furtherintermediate unit 501, then the control unit of the hub module and thatof one of the units 501 or 500 may, in one or more embodiments, be asingle control unit operating on at least two distinct software tasks inorder to execute the activities of hub module and interfaces.

Although illustrative and exemplary embodiments of various apparatus,processes, and systems have been described herein, it is to beunderstood that the invention is not to be limited to the disclosedembodiments, but on the contrary, is intended to cover variousmodifications and equivalent arrangements included within the spirit andthe scope of the appended claims.

Here below the components and corresponding reference numerals used inthe detailed description are listed.

Number Part P Patients  1 System 100 Clients unit 101 Memory of clientunit 102 Graphic user interface of client unit 103 Control unit ofclient unit 110 First display 111 First selection tool 112 First displayfield 113 Graphic representation 113a Point 113b Bar 113c Segment 114Graphic selector 115 X-Axis in first display field 116 Y-Axis in firstdisplay field 120 Second display 121 Second selection tool 122 Seconddisplay field 122a Display area 122b Display area 122c Display area 123Graphic representation 125 X-axis in second display field 126 Y-axis insecond display field 128 Selectable zones 130 Menu area 131 Firstselectable area 132 Second selectable area 133 Third selectable area 142Third display field 160 Auxiliary display 161 Table 162 List ofmonitored patients 163 List of indicators 164 Score 170 Switching tool180 Population filtration tool 300 Blood treatment machines 301 Controlunit of blood treatment machines 302 Sensors of blood treatment machines303 Memory of blood treatment machines 305 Device connected to bloodtreatment machine 307 Actuator 310 Blood circuit 311 Blood chamber 312Blood treatment unit 313 Dialysate chamber 315 Fresh dialysatepreparation circuit 316 Spent dialysate liquid circuit 317 Wastedischarge end 400 Lab storage unit 500 Intermediate elaborating unit 501Further Intermediate elaborating unit

1-34. (canceled)
 35. An apparatus of monitoring a plurality of patientsaffected by kidney failure over a time frame, the apparatus comprising amemory, a graphic user interface, and a control unit connected to thememory and to the graphic user interface, the apparatus being configuredfor connection to a system configured for collecting one or more of:values (V_(M)) of a plurality of session parameters measured by sensorsof blood treatment machines in the system during respective bloodtreatment sessions of each patient over said time frame, set values(V_(S)) of a plurality of prescription parameters, values (V_(L)) of aplurality of laboratory parameters comprising values relating tobiological fluid properties obtained from tests conducted on fluidsamples taken from each patient over said time frame, wherein theapparatus control unit is configured to: receive and store in theapparatus memory, for each patient, values (KPV_(i)) of selectedparameters (KP_(i)) comprising: values of a first subgroup of saidplurality of session parameters (V_(M)), set values of a second subgroupof said plurality of prescription parameters (V_(S)), and values of athird subgroup of said plurality of laboratory parameters (V_(L)),define, for each of said patients, a number of indicators (ID_(k))wherein each of said indicator is distinct from the other and is definedbased on the values (KPV_(i,k)) taken by a respective subclass(KP_(i,k)) of said selected parameters (KP_(i)).
 36. An apparatusaccording to claim 35, wherein the control unit is further configuredto: compare the values (KPV_(i,k)) taken, over the time frame (T), bythe subclasses of selected parameters (KP_(i,k)) affecting a sameindicator (ID_(k)) with respective reference criteria; signal whetherone or more of said criteria are not met.
 37. An apparatus according toclaim 35, wherein the control unit is configured to remotely connectwith a hub module and receive, at time intervals, the values (KPV_(i))of selected parameters (KP_(i)) contained in a hub module memory.
 38. Anapparatus according to claim 35, wherein the control unit is configuredto interrogate a hub module at a plurality of regular time intervalsduring said time frame in order to collect a plurality of sets of values(KPV_(i)) of selected parameters (KP_(i)), each set referring to arespective time interval.
 39. An apparatus according to claim 35configured for connection to said system, which is further configuredfor: storing, in a memory of a hub module part of the system, values(KPV_(i)) of selected parameters (KP_(i)) comprising: values of a firstsubgroup of said plurality of session parameters (V_(M)), set values ofa second subgroup of said plurality of prescription parameters (V_(S)),and values of a third subgroup of said plurality of laboratoryparameters (V_(L)).
 40. An apparatus according to claim 35, wherein thecontrol unit is configured for: operate in a first display modecomprising generating on said graphic user interface a first displayhaving a first selection tool for choosing one among said selectedparameters (KP_(i)) and a first display field showing, for each of aplurality of patients, a respective graphic representation of one ormore significant values taken by the chosen parameter across said timeframe; operate in a second display mode comprising generating on saidgraphic user interface a second display having a second selection toolfor choosing one among said indicators (ID_(k)) and a second displayfield showing, for one patient, a graphic representation of the values(KPV_(i,k)) taken, over the time frame, by the subclass of said selectedparameters (KP_(i,k)) affecting the selected indicator (ID_(k)); allow,when in said first display mode, choosing one patient and detectingselection of said one patient; and subsequently activate said seconddisplay mode and display said second display on the graphic userinterface wherein, in the second display mode, graphic representationsare displayed of the values (KPV_(i,k)) taken, over the time frame, bythe subclass of said selected parameters (KP_(i,k)) affecting theselected indicator (ID_(k)) and relating to the chosen patient.
 41. Anapparatus according to claim 40, wherein the control unit is configuredto: receive and store in the apparatus memory, for each patient (P), aprescribed number of the values (KPV_(i)) contained in a hub modulememory, define, for each of said patients, a number of indicators(ID_(k)) wherein each of said indicator is distinct from the other andis defined based on the values (KPV_(i,k)) taken by a respectivesubclass (KP_(i,k)) of said selected parameters (KP_(i)).
 42. Anapparatus according to claim 40, wherein the control unit is configuredto hide said first display when said second display mode is activated.43. An apparatus according to claim 40, wherein the control unit isconfigured to display said the graphic representations in side by siderelation in said first display field; wherein the control unit, in saidfirst display mode, is configured to detect the patient chosen bydetecting selection of one of said first graphic representations, andwherein detecting selection of one of said graphic representationscomprises detecting overlapping of a graphic selector with the chosenone among said first graphic representations, the graphic selectorgraphically differentiating the chosen first graphic representation fromthe other first graphic representations displayed on the first display.44. An apparatus according to claim 40, wherein the control unit isconfigured to display a menu area comprising a plurality of selectableareas, the plurality of selectable areas comprising at least a firstselectable area and a second selectable area, wherein the control unitis further configured to detect selection of the first selectable areaand to activate the first display mode when the first selectable area isselected and wherein the control unit is further configured to detectselection of the second selectable area and to activate the seconddisplay mode when the second selectable area is selected, and whereinthe control unit is configured to display the menu area both in saidfirst and in said second display modes.
 45. An apparatus according toclaim 44, wherein the first display field comprises a Cartesianrepresentation where one axis represents the patients and one other axisrepresents the measure of the values taken by the selected parameters(KP_(i)), and wherein each of said first graphic representationscomprises a representation of the mean value taken by the selectedparameter across said time frame (T) and a graphic representation of adistribution of values taken by the selected parameter around said meanvalue.
 46. An apparatus according to claim 40, wherein the control unit,in said first display mode, is configured to display on said graphicuser interface an auxiliary display comprising a table displaying a listof the monitored patients, the control unit being also configured toassociate an identification code to each patient and to detect thepatient chosen by detecting selection of the respective identificationcode.
 47. An apparatus according to claim 40, wherein the control unit,in said first display mode, is configured to display on said graphicuser interface a recap display comprising a table displaying a list ofmonitored patients, a list of said indicators (ID_(k)), and a scoreassociated to a number of indicators and patients, wherein each of thedisplayed scores is univocally associated to a respective patient and toa respective indicator (ID_(K)), the control unit being configured tocalculate each one of said scores based on a comparison of each of thevalues (KPV_(i,k)) taken, for the respective patient, by the subclass ofsaid selected parameters (KP_(i,k)) affecting the indicator (ID_(k)),with a respective reference criterion.
 48. An apparatus according toclaim 40, wherein the second selection tool comprises a plurality ofselectable zones, each of said selectable zones corresponding to arespective one of said indicators (ID_(k)), wherein the control unit isfurther configured to: detect selection of one indicator by detectingselection of the corresponding selectable zone, and display on saidsecond display the graphic representations of the values (KPV_(i,k))taken, over the time frame (T), by the subclass of said selectedparameters (KP_(i,k)) affecting the selected indicator (ID_(k)) andrelating to the chosen patient.
 49. An apparatus according to claim 40,wherein the control unit is configured to allow setting of said timeframe (T), wherein the control unit is configured to display in saidfirst display mode a time frame selection tool allowing the setting ofat least one of: a start of said time frame (T), an end of said timeframe (T), a start and an end of said time frame (T), and wherein saidtime frame (T) covers a plurality of blood treatment sessions.
 50. Anapparatus according to claim 40, wherein the control unit is configuredto allow setting of a population filtration criterion and wherein thecontrol unit, when in said first display mode, is configured to displaythe respective graphic representation of said one or more significantvalues, only for those patients satisfying the set population filtrationcriterion.
 51. An apparatus according to claim 50, wherein the controlunit, when in said first display mode, is configured to allow choosingone patient only among those satisfying the set population filtrationcriterion.
 52. An apparatus according to claim 51, wherein saidpopulation filtration criteria comprises one in the group of: acondition concerning one or more of the values (KPV_(i)) of selected theparameters (KP_(i)); conditions concerning one or more of saidindicators (ID_(k)).
 53. An apparatus according to claim 40, wherein thecontrol unit is configured to: allow an operator to choose one or moreindicators (ID_(k)) of interest, receive and store in the apparatusmemory, for each patient (P), only the values (KPV_(i)) contained in ahub module memory taken, over the time frame (T), by the subclass ofsaid selected parameters (KP_(i,k)) affecting the chosen indicators(ID_(k)).
 54. An apparatus according to claim 40, wherein the controlunit is configured to allow setting of a population filtration criterionand is configured to request a scan of a hub module memory, and receiveand store in the apparatus memory exclusively the values (KPV_(i)) ofselected parameters (KP_(i)) relating to patients satisfying thepopulation filtration criterion.
 55. An apparatus according to claim 40,wherein the control unit is configured to: allow, when in said seconddisplay mode, to choose one among the values taken by the parameters ofsaid subclass of selected parameters (KP_(i,k)) affecting the selectedindicator (ID_(k)); establish the treatment session corresponding to thechosen value; operate in a third display mode, comprising generating athird display on said graphic user interface having a third displayfield showing, for the chosen patient and for the treatment sessioncorresponding to the chosen value, a respective graphic representationof a plurality of values taken at different instants over sessiontreatment time by said a plurality parameters.
 56. An apparatusaccording to claim 40, wherein the control unit is configured tocalculate a sum and/or a mean value of said scores referring to a samepatient, and wherein the control unit is configured to rank patientsfrom the one having highest score to the one having lowest score.
 57. Anapparatus according to claim 46, wherein the control unit is configuredto display, when in said first display mode, a switching tool foralternatively displaying one of the first display, the auxiliary displayand the recap display, and wherein the control unit is furtherconfigured for associating to each of said scores a different graphicrepresentation depending upon the score value.
 58. An apparatusaccording to claim 40, wherein the control unit is configured to: storein said memory a plurality of population filtration criteria, display insaid first display mode a population filtration tool for the selectionof one population filtration criterion; detect the setting of apopulation filtration criterion.
 59. An apparatus according to claim 35,wherein the values of the first subgroup of said plurality of sessionparameters (V_(M)) include measured values for one or more of thefollowing parameters: blood flow rate, clearance or dialysance values,treated blood volume, K*Tr and or K*Tr/V where K is measured dialysance,Tr is treatment time and V a reference volume, dialysate conductivity,patient blood conductivity at the beginning and/or at the end of thetreatment session, transferred ionic mass, total weight loss, realsession duration, measures of cardiac parameters: systolic and diastolicarterial pressure (TA), cardiac rate, arterial and/or venous pressure,hemoglobin, e.g. obtained by calorimetric detection.
 60. An apparatusaccording to claim 35, wherein the set values of the second subgroup ofsaid plurality of prescription parameters (VS) include for each bloodtreatment session of each patient over said time frame T: duration ofthe blood treatment session, blood conductivity, blood flow rate,patient's dry weight, the calcium concentration for the dialysis liquid,the potassium concentration for the dialysis liquid, the blood flow ratein the extracorporeal circuit, the weight loss rate, the total weightloss to be achieved at the end of the treatment, the blood conductivityto be achieved at the end of the treatment, the dialysis dose.
 61. Anapparatus according to claim 35, wherein the values of the thirdsubgroup of the laboratory parameters (V_(L)) include values of: Ureaconcentration (pre and/or post treatment session) Creatinineconcentration (pre and/or post treatment session) Uric acidconcentration (pre and/or post treatment session) Sodium concentration(pre and/or post treatment session) Potassium concentration (pre and/orpost treatment session) Bicarbonate concentration (pre and/or posttreatment session) Phosphate concentration (pre and/or post treatmentsession) Calcium concentration (pre and/or post treatment session) Totalproteins concentration (pre and/or post treatment session) PTH(parathyroid hormone) Hemoglobin Ferritin Saturation coefficient AlbuminCRP (C-reactive protein) Total cholesterol LDL cholesterol TriglyceridesGlycemia beta-2-microglobuline Glycated hemoglobin KT/V Urea Systolicand diastolic arterial pressure (TA) measured while lying on a bedbefore and after treatment session Weight before and after treatmentsession.
 62. An apparatus according to claim 35, wherein the number ofindicators (ID_(k)) comprises one or more of the following dialysisindicators: a first indicator (ID₁) relating to the conditions of thevascular access—this indicator uses a first subclass of the KP_(i)including one or more of: measured values KPV_(M) for the blood flowrate, for the ionic dialysance and for the arterial and venouspressures; a second indicator (ID₂) relating to the prescriptionconformity—this indicator uses a second subclass of the KP_(i) includingone or more of: prescription values KPV_(S) for the duration of thetreatment, the blood and/or dialysate conductivity, the blood flow rate,and the patient's dry weight, and measured values KPV_(M) for thetreated blood volume, for the dialysate conductivity, for the totalweight loss and for the total session duration; a third indicator (ID₃)relating to potassium—this indicator uses a third subclass of the KP_(i)including one or more of: prescription values KPV_(S) for the dialysatepotassium and laboratory parameter values KPV_(L) for the potassiumconcentration in blood; a fourth indicator (ID₄) relating to anemia—thisindicator uses a fourth subclass of the KP_(i) including one or more of:measured values KPV_(M) for hemoglobin and laboratory parameter valuesfor hemoglobin, ferritin and saturation coefficient; a fifth indicator(ID₅) relating to nutrition and metabolism—this indicator uses a fifthsubclass of the KP_(i) including one or more of: laboratory parametervalues KPV_(L) bicarbonate, blood sugar, total proteins, albumin, CRP; asixth indicator (ID₆) relating to phosphorous-calcium equilibrium—thisindicator uses a sixth subclass of the KP_(i) including one or more of:laboratory parameter values KPV_(L) for phosphate, calcium, PTH; aseventh indicator (ID₇) relating to hypertension—this indicator uses aseventh subclass of the KP_(i) including one or more of: prescriptionvalues KPV_(S) for plasmatic conductivity (initial and/or final) and fordialysate conductivity; laboratory parameter values KPV_(L) for sodiumconcentration in blood (before and/or after treatment), cardiacparameters (systolic and diastolic pressure, heart rate), weight beforeand after treatment; and measured values V_(M) for dialysateconductivity, blood conductivity before and after treatment session,ionic mass transfer, total weight loss, cardiac parameter measures(systolic and diastolic pressure and heart rate); an eighth indicator(ID₈) relating to dialysis dose—this indicator uses an eight subclass ofthe KP_(i) including one or more of: laboratory parameter values KPV_(L)for urea and creatinine concentration in blood pre and post session andfor beta-2-microglobuline and KT/V urea; and measured values V_(M) forthe total treated blood volume and the measured KT and KT/V. wherein thecontrol unit compares each of the values KPV_(i,k) taken, over the timeframe T, by the subclasses of selected parameters KP_(i,k) affecting asame indicator (ID_(k)) with respective reference criteria and detectspossible drifts compared to what is regarded as a reference criterion ofnormality.
 63. An apparatus according to claim 62, wherein the controlunit is configured to apply one or more of the following referencecriteria in order to classify if the patient's status for each singleID_(k) is acceptable, not acceptable or lies in an area uncertainty: forthe first indicator (ID₁): the ionic dialysance measured values arecompared with a reference; the patient's status is considered acceptableif the last 3 measures are >than 165 ml/min, not acceptable if the last3 measures are <than 155 ml/min, and potentially critical in all othercases; for the second indicator (ID₂): the status is consideredacceptable if the measured values for the parameters affecting thisindicator are identical or fall within a strict acceptable rangecompared to the respective set values; for the third indicator (ID₃):the patient's status is considered acceptable if the last 3 measures forthe potassium concentration in blood are <than 5.5 mmol/l, notacceptable if the last 3 measures for the potassium concentration inblood are >than 5.5 mmol/l, and potentially critical in all other cases;for the fourth indicator (ID₄): the patient's status is consideredacceptable if the last 3 values for hemoglobin fall within 10 and 12g/l; the patient's status is considered not acceptable if the last 3values for hemoglobin are either above 13 g/l or below 10 g/l; thepatient's status is considered potentially critical in all other cases;for the fifth indicator (ID₅): the patient's status is consideredacceptable if the following conditions are all met: albuminconcentration>32g/l, urea concentration>1.1 g/l, creatinineconcentration>60 mg/l, phosphorus concentration>34 mg/l, potassiumconcentration>4.5 mmol/l; the patient's status is considered notacceptable if the following conditions are all not met: albuminconcentration<32g/l, urea concentration<1.1 g/l, creatinineconcentration<60 mg/l, phosphorus concentration<34 mg/l, potassiumconcentration<4.5 mmol/l; the patient's status is considered potentiallycritical in all other cases; for the sixth indicator (ID₆): thelaboratory values for phosphorous, calcium and PTH are compared withrespective references; the patient's status is considered acceptable ifthe last 3 values for phosphorous lie within 34 and 60 mg/l, and thelast 3 values for calcium lie within 88 and 100 mg/l, and PTH last valueis comprised within 100 and 300 μg/l; the patient's status is considerednot acceptable if the last 3 values for phosphorous are above 60 mg/l;the situation is considered potentially critical in all other cases; forthe seventh indicator (ID₇): the patient's status is considered notacceptable if the last 3 values for pre-dialysis session arterialpressure TA are above 170 mm Hg; the patient's status is consideredacceptable if the last 3 values for pre-dialysis session arterialpressure TA are below 150 mm Hg; the patient's status is consideredpotentially critical in all other cases; for the eight indicator (ID₈):the measured KT values are compared with a reference; the patient statusis considered acceptable if the last 3 measures are >than 40 liters, notacceptable if the last 3 measures are <than 36 ml/min, and potentiallycritical in all other cases. In case of less than 3 measures in the last15 days, then the assessment is not considered reliable and discarded.64. An apparatus according to claim 35, wherein said set values (V_(S))of a plurality of prescription parameters include one or more of: valuesof a plurality of session parameters set for blood treatment sessions ofeach patient over said time frame, values representative of medicamentprescriptions which have been imparted to each patient over said timeframe, and values representative of one or more disposable items usedduring blood treatment sessions of each patient over said time frame.65. An apparatus according to claim 36, wherein, to signal whether oneor more of said criteria are not met, the apparatus is furtherconfigured to activate an alarm in response to one or more of saidcriteria not being met.
 66. An apparatus according to claim 36, wherein,to signal whether one or more of said criteria are not met, theapparatus control unit is further configured to indicate via the graphicuser interface whether each criterion of the one or more said criteriais non-acceptable or only potentially susceptible of being problematic.